Last verified: July 31, 2026 · FDA source snapshot: July 30, 2026 · Dataset version: 2026-07-31
GLP-1 Consumer Research is an independent research and reference resource published by Weight Loss Provider Guide.
Compounded semaglutide recalls have affected specific products, firms and lots — not every compounded semaglutide product. In the FDA drug-enforcement export dated July 30, 2026, our record-by-record audit identified 14 distinct U.S. recall events involving finished compounded or repackaged semaglutide, containing 36 semaglutide product records. Records with countable quantities list at least 68,945 vials and 256 prefilled syringes; one additional record reports 800.5 mL in unit-dose vials, and three records state no quantity. Every one of the 36 included semaglutide records is classified Class II.
The FDA records reviewed for this tracker do not show a blanket recall of all compounded semaglutide.
Coverage: recall initiation dates from March 7, 2022 through March 6, 2026. Source: Weight Loss Provider Guide Research analysis of FDA drug-enforcement records. FDA source snapshot July 30, 2026; records verified July 31, 2026. Vials, syringes and milliliters are kept as separate units.
The complete compounded semaglutide recall tracker
The July 30, 2026 FDA source snapshot contains 14 distinct finished-product events that meet this tracker’s inclusion rules. The table below reports each event once, then shows how many semaglutide product records sit inside it.
Table 1. U.S. recall events involving finished compounded or repackaged semaglutide, 2022–2026
Source: Weight Loss Provider Guide Research analysis of FDA drug-enforcement records. Events are grouped by FDA event ID. Quantities are reproduced in the units FDA reported. FDA source snapshot July 30, 2026; records verified July 31, 2026.
First, an event is not a product. FDA’s Product View displays individual recalled products, while its Event View groups the products connected to one recall action. One event can contain several semaglutide strengths or presentations — and, sometimes, entirely unrelated drugs. A raw search-result count therefore is not an event count.
Second, the recalling firm initiates the recall. FDA defines the recalling firm as the firm that initiates the action, then FDA evaluates and classifies the individual recalled products. The accurate wording is that the firm initiated a recall and the products appear in FDA Enforcement Reports — not that FDA personally initiated every recall.
Is compounded semaglutide recalled?
Some compounded semaglutide products have been recalled. The FDA records reviewed here do not show that all compounded semaglutide was recalled. Each of the 14 finished-product events applies to identified firms, formulations, presentations, lots or distribution periods — not to the category as a whole.
A product that does not appear here has not been declared safe. It simply is not part of a qualifying federal Enforcement Report record in this dataset.
What “recall” means in this tracker
A recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of laws it administers and against which the agency would initiate legal action. Most recalls are voluntary. FDA monitors the action, evaluates the hazard and assigns a classification.
A recall event is the FDA-tracked action. A product record is one specific recalled item within that event, carrying its own recall number.
FDA event 97808 shows why this distinction matters. The ProRx action initiated October 15, 2025 contains seven product records: six semaglutide records and one tirzepatide record. In this tracker, that is one compounded semaglutide recall event, six semaglutide product records and one excluded tirzepatide product record.
The same record-level rule prevents unrelated fluorescein, lidocaine/epinephrine, NAD+, tirzepatide and other products from inflating the semaglutide totals.
Why a recall number ending in 2026 can belong to an event initiated in 2025
FDA’s recall procedures say the year at the end of a recall number is the fiscal year in which the product was classified, not necessarily the calendar year in which the firm initiated the action.
That is why the ProRx event initiated October 15, 2025 carries drug recall numbers D-0114-2026 through D-0120-2026. The suffix is not evidence that the recall began in 2026. Timing should be taken from the initiation and classification fields, not inferred from the recall number alone.
Compounded semaglutide recall statistics: 14 events and 36 product records
The 14 included events contain 36 semaglutide product records. Records with countable quantities list at least 68,945 vials, 256 prefilled syringes and 800.5 mL in unit-dose vials; three records state no quantity. Those quantities cannot be collapsed into one honest “units recalled” figure because the units are not interchangeable.
Table 2. Compounded semaglutide recalls by year of initiation
Year initiated
Events
Semaglutide product records
Quantity as reported
2022
4
7
15,835 vials; 32 syringes; 800.5 mL; 1 record without quantity
2023
2
2
54 vials
2024
1
4
13,346 vials
2025
5
20
38,797 vials; 224 syringes; 2 records without quantity
2026 through the July 30 source snapshot
2
3
913 vials
Total
14
36
≥68,945 vials; 256 syringes; 800.5 mL; 3 records without quantity
Source: Weight Loss Provider Guide Research analysis of FDA drug-enforcement records, source snapshot July 30, 2026. Units are not summed across vials, syringes and milliliters.
The earliest qualifying event we located was initiated March 7, 2022. That is the earliest event in this dataset, not a claim that it was the first compounded semaglutide recall that ever occurred.
The countable vial total is extremely concentrated
Three events account for 65,273 of the 68,945 countable vials — 94.7% of the vial total. Two of those three events involve ProRx LLC.
Table 3. Concentration of countable vial quantities
Source: Weight Loss Provider Guide Research calculation from FDA-reported quantities. Percentages use the 68,945 countable vials only and exclude syringes, milliliters and records without a stated quantity.
The large aggregate vial count does not describe an even spread across firms or events. Most of the vial total comes from three actions. The event count and the quantity count answer different questions and should stay separate.
The largest event contained about 278.6 grams of labeled semaglutide
For FDA event 97808, multiplying each semaglutide product record’s labeled milligrams per vial by its reported vial quantity produces 278,572 mg, or about 278.6 grams, of labeled semaglutide content.
Table 4. Labeled semaglutide content in FDA event 97808
Product presentation
Reported vials
Labeled semaglutide per vial
Labeled content
12.5 mg/5 mL
2,809
12.5 mg
35,112.5 mg
10 mg/4 mL
8,400
10 mg
84,000 mg
6 mg/2.4 mL
8,310
6 mg
49,860 mg
8 mg/3.2 mL
11,119
8 mg
88,952 mg
2.5 mg/1 mL
2,649
2.5 mg
6,622.5 mg
5 mg/2 mL
2,805
5 mg
14,025 mg
Total
36,092
278,572 mg — 278.6 g
Source: Weight Loss Provider Guide Research calculation from the product descriptions and quantities in FDA event 97808. This is labeled content, not delivered dose, recovered quantity or patient exposure.
No patient count can be derived from that figure. Multidose use, titration, overfill, wastage, dispensing and recovery are not reported in the event record.
Why the event count can change
FDA says openFDA drug-enforcement data comes from the Recall Enterprise System and is generally updated weekly. A later export can add a new event, add or correct a product record, change a quantity, or clarify an existing record.
That is why this page shows both the FDA source-snapshot date and the date the included records were rechecked. Neither date should move unless a real source review occurred.
What this data shows — and what it does not show
This dataset describes FDA-monitored recall records. It does not describe patient outcomes. It can identify products, recalling firms, dates, reasons, classifications and quantities. It cannot establish how many people were exposed or whether a particular patient was harmed.
It shows:
How many distinct finished-product events meet the stated inclusion rules
How many semaglutide product records those events contain
The recalling firms, initiation dates, FDA event IDs, classifications and stated reasons
Quantities in FDA’s own units where FDA reported them
The concentration of countable vial quantities in a few large events
The distribution of FDA-stated recall reasons across this event set
It does not establish:
How many patients used a recalled product
How many recalled units reached patients
How many units were recovered, destroyed or corrected
Whether a particular patient was injured
The overall defect rate for compounded semaglutide
The comparative safety of compounded and FDA-approved semaglutide
That a product absent from the table is safe
Whether every state-level withdrawal or board action appears in the federal data
Whether FDA will later correct, expand or reclassify a record
Compounded drugs are not FDA-approved. FDA does not review them for safety, effectiveness and quality before marketing. That is important context, but it is not a finding that every compounded product is defective or recalled.
This page is educational and does not direct a reader to start, stop or change a prescription.
How we built the compounded semaglutide recall dataset
We reviewed FDA drug-enforcement records containing semaglutide, grouped matching product records by FDA event ID, removed unrelated products inside mixed events, and preserved the quantity units FDA reported. The underlying openFDA export was dated July 30, 2026 and contained 17,832 drug-enforcement records. The included semaglutide records were rechecked at the event and product-record level on July 31, 2026.
Inclusion rules
A record is included when all of the following hold:
The product description identifies semaglutide.
The record represents a finished compounded or repackaged medication.
The record belongs to an FDA-monitored drug-enforcement event with a retrievable event ID.
The event, product, classification and FDA-stated reason can be traced to the source record.
Any quantity is reproduced in FDA’s own unit without conversion.
Exclusion rules
A record is excluded from the 14-event finished-product total when:
It is tirzepatide or another drug appearing under the same event ID
It is branded Wegovy or Ozempic
It is bulk semaglutide active pharmaceutical ingredient rather than a finished medication
The only source is a warning letter, adverse-event report, counterfeit alert, inspection record or state board action without a corresponding qualifying Enforcement Report record
It duplicates a product record already counted
Finished compounded or repackaged status cannot be established
Four record-level corrections this method catches
These are not abstract methodology notes. They change the numbers.
Boothwyn, event 97202 — the classification trap.
The event contains an unrelated fluorescein record classified Class III. The three semaglutide records are Class II. Reading one event-level class and applying it to every product gives semaglutide the wrong classification.
Vital Care, event 90982 — the quantity trap.
The semaglutide record reports 800.5 mL in unit-dose vials. A separate seven-syringe quantity belongs to an unrelated lidocaine/epinephrine record and is excluded.
GenoGenix, event 97369 — the unrelated-product trap.
The event contains many sterile injectable products. Only two records identify semaglutide. An NAD+ product and the other unrelated products are excluded.
ProRx, New Life and Aequita — the sibling-drug trap.
These events contain tirzepatide alongside semaglutide. Every tirzepatide row and quantity is excluded from the semaglutide totals.
Quantity rules
Vials remain vials, syringes remain syringes and volume remains milliliters
A missing quantity is marked “not stated,” never estimated as zero
Totals use “at least” when one or more included records lack quantity
Vial counts are not inferred from milliliters
Dose counts and patient counts are not inferred from vials or syringes
Quantity subject to recall is not treated as quantity administered or quantity recovered
Cause classification
FDA’s exact stated reason remains visible in every table. For one summary calculation, this page groups “lack of assurance of sterility” and “lack of processing controls” under the editorial heading quality or sterility assurance. That is our analytical grouping, not an FDA recall category.
How recall status is handled
FDA says its openFDA enforcement data should not be used to track the lifecycle of a recall and says the published status remains unchanged after classification. A status value in a historical export therefore is not enough to declare that a recall is currently open, completed or terminated. This page does not make current-status claims from the export.
Reproducibility
The public event-level CSV contains one row per included finished-product event, the source event URL, source-snapshot date and verification date.
Dataset version: 2026-07-31
FDA export date: 2026-07-30
FDA export record count: 17,832
Published event-level CSV SHA-256:2f80012c2f046a0029e371bbdd86ee8190770ecea27b0f56739954c20df0f9d7
FDA states that openFDA drug-enforcement data comes from the Recall Enterprise System, is generally updated weekly and may be corrected after publication. The visible verification date changes only after a real source review.
Which pharmacies and products were recalled?
The 14 events involve 11 distinct recalling-firm identities. Three firm groups appear in more than one event: ProRx LLC, the entities operating as Tailor Made Compounding, and Pharmacy Plus / Vital Care Compounder. Table 1 lists every event. The record-level arithmetic for the two largest ProRx events follows because together they account for most of the countable vial total.
ProRx event 97808: 36,092 semaglutide vials
FDA event 97808 was initiated October 15, 2025 and distributed in Texas and Utah. Six semaglutide records total 36,092 vials. One tirzepatide record in the same event is excluded.
Source: FDA Enforcement Report event 97808. Reason for the included semaglutide records: lack of assurance of sterility. All six included semaglutide records are Class II.
FDA event 95190 was initiated August 22, 2024 and distributed nationwide. Four semaglutide records total 13,346 vials. Three tirzepatide records in the same event are excluded.
Source: FDA Enforcement Report event 95190. Reason for the included semaglutide records: lack of assurance of sterility. All four included semaglutide records are Class II. Three tirzepatide records totaling 3,258 vials are excluded.
FDA’s amended ProRx warning letter, dated March 4, 2025, says the agency inspected the firm’s Exton, Pennsylvania facility from July 15 through August 2, 2024 and acknowledges the August 22, 2024 voluntary recall. The letter describes sterile-production deficiencies, missing required label information, use of bulk drug substance from an establishment FDA said was not registered, and inadequate adverse-event-reporting procedures. Those inspection findings provide context for the 2024 event; they are not added to the recall count as a second action.
The rest of the event record
2026 — Payless Compounders / Northwest Compounders: 91 vials. New Life Pharma / Nomida: 822 vials across two semaglutide records. Both events cite lack of assurance of sterility.
2025 — five events and 20 product records: ProRx, Boothwyn Pharmacy, Aequita Pharmacy, GenoGenix and Thrive Health and Wellness. Boothwyn is the only potency event in the finished-product dataset.
2024 — one event: ProRx, 13,346 semaglutide-containing vials.
2023 — two events: Tailor Made Compounding, 9 vials; and Pharmacy Plus / Vital Care Compounder, 45 vials.
2022 — four events: Tailor Made / TMC Acquisition, 15,835 vials; Carolina Infusion, 32 syringes; Pharmacy Plus / Vital Care Compounder, 800.5 mL in unit-dose vials; and Pharmacy Innovations, quantity not stated.
Why were compounded semaglutide products recalled?
Twelve of the 14 finished-product events cite lack of assurance of sterility. One cites lack of processing controls. One cites a subpotent product. Under the disclosed editorial grouping, 13 events involve quality or sterility assurance and one involves potency.
Table 7. Reasons for recall, as stated in FDA records
FDA-stated reason
Events
Semaglutide product records
Editorial grouping
Lack of assurance of sterility
12
27
Quality / sterility assurance
Lack of processing controls
1
6
Quality / sterility assurance
Subpotent product
1
3
Potency
Total
14
36
Source: Weight Loss Provider Guide Research tabulation of FDA reason-for-recall fields. “Quality / sterility assurance” is an editorial grouping, not an FDA category.
“Lack of assurance of sterility” is not the same statement as “contamination was found”
The phrase describes a failure to establish or maintain the controls and evidence needed to assure sterility. The reason field does not, by itself, say that microorganisms were detected in the product.
That distinction is not an all-clear. Injectable products depend on sterile-process controls. The accurate language is the language in the record: lack of assurance of sterility.
Subpotency is a different failure
Boothwyn Pharmacy’s three semaglutide records — 1,476 vials total — were recalled as subpotent. A subpotent product contains less active ingredient than labeled and may deliver less drug than prescribed. It is the only potency event in the 14-event finished-product dataset.
Aequita’s reason stays separate
Aequita Pharmacy’s event cites lack of processing controls. It is grouped with quality or sterility assurance only for the summary table. The exact FDA reason remains visible so the grouping can be reproduced or rejected.
What does a Class II compounded semaglutide recall mean?
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. All 36 included semaglutide product records are Class II.
FDA’s three recall classes are:
Class I — reasonable probability that use or exposure will cause serious adverse health consequences or death
Class II — use or exposure may cause temporary or medically reversible adverse health consequences, or serious consequences are remote
Class III — use or exposure is not likely to cause adverse health consequences
None of the 36 included semaglutide product records is Class I. That finding is limited to the semaglutide records included here. It does not describe unrelated products that happen to share an event ID.
Why the Boothwyn event is easy to misclassify
Boothwyn’s event contains an unrelated fluorescein record classified Class III. The three semaglutide records are Class II. A page-level scrape can therefore produce the wrong class even when it finds the correct event.
Was bulk semaglutide active ingredient recalled?
Yes. FDA event 98438 covers two Class II bulk semaglutide active-pharmaceutical-ingredient records intended for prescription compounding. The event is tracked separately because upstream API and finished dispensed medication are different units and cannot be combined into the 14-event finished-product total.
1 g, 5 g, 10 g, 25 g and 50 g; the second record also lists 100 g
Not stated
II
CGMP deviations involving process validation and bacterial-endotoxin method validation
Source: FDA Enforcement Report event 98438. This bulk-ingredient event is excluded from all finished-product event, record and quantity totals on this page.
FDA’s May 1, 2026 warning letter to Harbin Jixianglong Biotech gives more detail than the enforcement record alone. FDA says the firm:
Bought two semaglutide API batches from suppliers that were not on its approved supplier list
Repackaged and relabeled the material without documentation
Created new batch numbers, CP-030-20250711 and CP-030-20250911
Identified itself as the manufacturer instead of the firms that made the API
Changed manufacturing and retest dates without appropriate supporting data
Distributed the first batch to the United States on August 23, 2025 and the second on October 3, 2025
The warning letter says FDA recommended removal of the two batches on February 10, 2026 and that the firm initiated a voluntary recall on February 19, 2026. The Enforcement Report lists February 13, 2026 as the recall initiation date. Both dates are FDA dates, and both are disclosed rather than silently choosing one.
Using the warning letter’s dates, 180 calendar days elapsed between the first batch’s documented U.S. distribution and the February 19 recall date; 139 days elapsed for the second batch. Those are distribution-to-recall intervals, not estimates of patient exposure.
Why a bulk-ingredient recall is harder for a patient to trace
A finished-product recall can often be checked against the dispensing pharmacy, formulation, strength, lot and beyond-use date on the container. A finished-product label may not identify the upstream API supplier or the supplier’s batch number.
For an API-level event, the dispensing pharmacy’s purchasing and compounding records are the route to traceability. FDA’s records do not state how many pharmacies received these batches, how much material was compounded, how much reached patients or how many finished products were affected. No patient count can be reproduced from this event.
Is every FDA semaglutide alert a recall?
No. Recall events, warning letters, dosing-error communications, adverse-event reports, counterfeit notices, branded-product recalls and bulk-ingredient actions are different records with different meanings. Combining them creates a false recall count.
Table 9. What counts as a compounded semaglutide recall in this tracker
Record type
In the 14-event total?
Treatment in this dataset
Finished compounded semaglutide product
Yes
Included and grouped by FDA event ID
Repackaged finished semaglutide
Yes, with a scope note
Included when the record meets the finished-product rules
Multiple semaglutide strengths in one event
One event, multiple records
Counted once as an event and separately as product records
Unrelated drug under the same event ID
No
Excluded from semaglutide counts and quantities
Bulk semaglutide active ingredient
No
Tracked separately in Table 8
Branded Wegovy or Ozempic recall
No
Outside the compounded or repackaged finished-product scope
Counterfeit notice
No
Classified as a counterfeit alert, not a recall event
FDA warning letter or inspection record
No, unless a qualifying recall record also exists
Context only
Dosing-error safety communication
No
Safety communication, not a recall
Adverse-event report
No
Pharmacovigilance data, not a recall
State board action
No
Separate state regulatory record
Forum or social-media report
No
Never used as recall evidence
Source: Weight Loss Provider Guide Research inclusion and exclusion rules, dataset version 2026-07-31.
Adverse-event reports are not recall events or confirmed injuries
As of May 31, 2026, FDA reported receiving 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide.
Three facts have to stay attached to the 990 figure:
FDA says it is not always possible to determine whether the drug directly caused the reported event.
FDA says compounded-drug adverse events are likely underreported because federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit them.
FDA says many reported events appear consistent with adverse events associated with the FDA-approved versions.
The 990 figure is not a recall count, not a count of confirmed injuries and not part of any total on this page.
Warning letters are not recall events
A warning letter is a formal FDA compliance communication. It does not, by itself, remove a product from the market. A recall enters this tracker only when a qualifying FDA Enforcement Report record independently documents the action.
Branded semaglutide recalls are outside the total
Wegovy and Ozempic are FDA-approved branded products. A branded-product recall can involve semaglutide without being a compounded semaglutide recall. Branded events are excluded from the 14-event and 36-record totals.
How can you check whether your compounded semaglutide is affected?
Compare the dispensing pharmacy, product name, added ingredients, strength, container type, lot number and beyond-use or expiration date against the official recall record. If the information matches — or the label does not contain enough information to decide — contact the dispensing pharmacy or prescribing clinician for product-specific instructions.
Information to locate first:
Dispensing pharmacy name and phone number
Product name and formulation, including cyanocobalamin, glycine or B12 when present
Strength or concentration, such as 2.5 mg/mL
Presentation: multidose vial, single-dose vial or prefilled syringe
Lot number
Beyond-use date or expiration date
Prescription number and date dispensed
If the lot number is missing
Contact the dispensing pharmacy and ask it to trace the lot used to fill the prescription from its records. That is the right place to resolve an incomplete label. This page does not tell a reader to stop, continue or discard a prescription based on a general list.
If the recall is at the ingredient level
A finished-product label may not identify the API supplier or upstream batch. Ask the dispensing pharmacy whether it can trace the API supplier and batch used for the prescription.
Reporting a suspected problem
FDA encourages health professionals, patients and compounders to report adverse events or product-quality problems through its MedWatch program. FDA provides online reporting and a downloadable form that can be submitted by fax.
Limitations
These limits are part of the dataset, not fine print.
The scope is federal Enforcement Report records. The tracker does not claim to enumerate every state board action, private market withdrawal or correction handled outside FDA’s monitored recall system.
The Enforcement Report is not a real-time alert feed. FDA says firms may notify customers before FDA completes classification and posts the products. New or not-yet-classified actions may not yet appear in the source snapshot.
Three product records state no quantity. Two are in the GenoGenix event and one is in the Pharmacy Innovations event. Quantity totals therefore use “at least.”
Quantities are not patient outcomes. Product quantity does not establish how much reached patients, how much was administered, how much was recovered or whether anyone was harmed.
Incompatible units remain separate. Vials, syringes and milliliters are not combined into one total.
The bulk API event reports no product quantity. Package sizes do not establish how many packages were recalled or how much API entered finished products.
Historical status fields are not treated as current lifecycle data. FDA specifically says openFDA enforcement data should not be used to track recall lifecycle. This page does not label an event currently open or closed from that field alone.
FDA can correct its records. A later source export may add products, expand lots, change quantities or clarify an event.
“Lack of assurance of sterility” is not a statement that contamination was detected. The phrase is reproduced as FDA states it.
This is not medical advice. Product-specific decisions belong with the dispensing pharmacy and prescribing clinician.
Frequently asked questions about compounded semaglutide recalls
Was all compounded semaglutide recalled?
No. The FDA records reviewed for this tracker identify 14 firm- and product-specific finished-product events, not a blanket recall of every compounded semaglutide product.
How many compounded semaglutide recalls are in the tracker?
The FDA source snapshot dated July 30, 2026 produced 14 distinct finished-product events containing 36 compounded or repackaged semaglutide product records under the published inclusion rules.
How much compounded semaglutide was recalled?
Records with countable quantities list at least 68,945 vials and 256 prefilled syringes. One additional record reports 800.5 mL in unit-dose vials, and three product records state no quantity. The units remain separate.
Which pharmacies recalled compounded semaglutide?
Eleven distinct recalling-firm identities appear across the 14 events: ProRx LLC; GenoGenix LLC; Aequita Pharmacy; Boothwyn Pharmacy LLC; Thrive Health and Wellness LLC; Payless Compounders LLC / Northwest Compounders; New Life Pharma LLC / Nomida; Tailor Made Compounding / TMC Acquisition LLC; Pharmacy Plus Inc. dba Vital Care Compounder; Pharmacy Innovations; and Carolina Infusion LLC.
Was ProRx semaglutide recalled?
Yes. ProRx initiated an August 2024 event containing 13,346 semaglutide-containing vials and an October 2025 event containing 36,092 semaglutide vials. Both cite lack of assurance of sterility and all ten included semaglutide records are Class II. Together, the two events account for 49,438 countable vials, about 71.7% of the vial total in this dataset.
Why was compounded semaglutide recalled?
Twelve of the 14 finished-product events cite lack of assurance of sterility, one cites lack of processing controls and one cites a subpotent product.
What does a Class II recall mean?
FDA assigns Class II when use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. All 36 included semaglutide records are Class II.
Was bulk semaglutide ingredient recalled?
Yes. FDA event 98438 contains two Class II bulk semaglutide API records. That event is tracked separately and excluded from the finished-product totals.
Is a Wegovy or Ozempic recall the same thing?
No. Wegovy and Ozempic are FDA-approved branded semaglutide products. Their recalls are outside the compounded or repackaged finished-product scope of this tracker.
Is an FDA warning letter the same as a recall?
No. A warning letter is a compliance communication. This tracker counts a product only when a qualifying FDA Enforcement Report record independently documents a recall.
Does 990 adverse-event reports mean 990 injuries?
No. FDA says it is not always possible to determine whether the drug directly caused a reported event. The figure is not a recall count and not a count of confirmed injuries.
Does a recall prove that patients were harmed?
No. An Enforcement Report record documents a product problem and recall action. It does not establish how many units reached patients or whether a specific patient was harmed.
How do I know whether my vial was recalled?
Compare the dispensing pharmacy, formulation, strength, presentation, lot number and beyond-use or expiration date on the label with the official event record. Contact the dispensing pharmacy or prescribing clinician when the information matches or is incomplete.
Primary sources
FDA enforcement system, procedures and definitions
Initial publication from the July 30, 2026 FDA drug-enforcement snapshot; all included event and product-record totals reconciled
14 events; 36 product records
How to cite this page
WPG Research Team. “Compounded Semaglutide Recalls: FDA Tracker and Data, 2022–2026.” Weight Loss Provider Guide Research. Last verified July 31, 2026. https://weightlossproviderguide.com/research/compounded-semaglutide-recalls
To cite the dataset specifically:
WPG Research Team. “Compounded Semaglutide Recall Tracker, 2022–2026.” Dataset version 2026-07-31. Weight Loss Provider Guide Research. https://weightlossproviderguide.com/research/data/compounded-semaglutide-recall-tracker-events-2026-07-31.csv
GLP-1 Consumer Research is an independent research and reference resource that documents U.S. weight-management safety, access and regulatory records using public primary sources. This article and dataset contain no paid placement, affiliate links, lead routing or treatment recommendations.