Peptide recalls: FDA records and affected lots

By Peptide Care Index · Updated October 2026

Peptide recalls affect named products and lots. This register documents 10 selected U.S. recall actions from 2019–2026 involving compounded, unapproved, or bulk peptide drug products. It includes BPC-157, GHK-Cu, sermorelin, semaglutide, and tirzepatide. Check the dates and lot details below; separate tables cover manufactured prescription drugs and collagen supplements.

What are the key peptide recall facts?

• 10 selected recall actions: the main register covers U.S. actions dated May 23, 2019, through February 25, 2026. Each row links to an FDA source that confirms a recall. This is the register’s coverage, not the total number of U.S. peptide recalls.
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• BPC-157 lot GG012825-002: FDA record D-0085-2026 identifies GenoGenix BPC-157 injection, 15 mg/10 mL, recalled for lack of sterility assurance. The recall began July 30, 2025.
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• 57 product records, one event: the GenoGenix FDA event export contains 57 distinct recall numbers under event 97369 in the October 7, 2026 snapshot. They include peptide and non-peptide drugs. They are not 57 separate recall events.
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• Seven named lots: Innoveix’s July 12, 2021 announcement lists three sermorelin/ipamorelin lots and four AOD-9604 lots for lack of sterility assurance. FDA source 7
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• Three peptide lots in an 11-lot notice: Olympia’s March 10, 2022 announcement lists two sermorelin lots and one sincalide lot among 11 lots across seven compounded product names. The reason was out-of-specification results. FDA source 6
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• Two raw-ingredient batches: FDA confirms Harbin Jixianglong recalled two semaglutide API batches on February 19, 2026. An API is the active ingredient used to make a drug; this was not a notice recalling every semaglutide medicine. FDA source 2
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Jump to: Recall register · BPC-157 and other affected lots · Historical lot lists · Prescription-drug examples · Collagen · Check your product · Method and downloads

Which peptide recalls are documented in this register?

The table records 10 selected recall actions, with the recall date or announcement date labeled. Five rows use a later FDA letter that explicitly confirms a recall. The other five use company recall announcements hosted by FDA. A warning letter is included only when its text confirms that a recall occurred.

Sources: FDA pages linked in each row, checked October 14, 2026. “Announced” is a company announcement date; it is not a verified initiation date. Several actions also covered non-peptide products. An older notice is a historical record, not a statement that a recall remains active today.

Use the firm name as well as the ingredient. A ProRx tirzepatide lot and a GenoGenix tirzepatide lot are different products with different recall records.

Was BPC-157 recalled, and which other GenoGenix peptide lots were affected?

Yes. FDA record D-0085-2026 names GenoGenix BPC-157 injection lot GG012825-002 within expiry. The recall began July 30, 2025, for lack of sterility assurance. The product description also includes labeling for Medical Health Institute, or MHI. The record does not say that all BPC-157 products from every seller were recalled.

The table below shows 11 selected peptide product records within the same GenoGenix event. Every row is Class II and marked Ongoing in the October 7, 2026 API snapshot, retrieved October 14. These are dated database fields, not a live clearance check.

Source: the exact FDA record linked in each row; full event export. Each record lists July 30, 2025 as the initiation date and lack of sterility assurance as its reason. “Within expiry” is part of the recorded recall scope; it is not a new expiry date.

The full event contains other drugs, including NAD+. NAD+ is not a peptide. Its Class I record and the patient reports described in FDA’s letter must not be assigned to the BPC-157 record. The full download keeps every product so readers can see the difference.

A label saying TB-500 also needs care. The FDA entries above identify thymosin beta-4 (TB4) and a BPC-157/TB4 combination. A similar name on a different seller’s vial is not enough to match it to those records.

Why does a 2025 recall have a 2026 recall number?

For BPC-157 record D-0085-2026, FDA supplies three separate dates: initiation on July 30, 2025; report date October 15, 2025; and classification date October 21, 2025. The year at the end of a recall number cannot replace the initiation date. See the original record.

Sources: FDA product record and FDA field definitions. FDA distinguishes a recall event from its individual recalled products.

Which sermorelin, ipamorelin, and AOD-9604 lots appear in the older notices?

Innoveix’s July 2021 notice lists seven lots of two products. Olympia’s March 2022 notice lists three sermorelin or sincalide lots within a larger mixed-product action. These historical codes are useful for checking old records; the tables do not establish current recall status.

Source: FDA source 7, checked October 14, 2026. The source spells the first ingredient “Semorelin.” We use “sermorelin” for reading and search, while preserving the source spelling in the action dataset. The space in AOD 215 is retained.

Source: FDA source 6, checked October 14, 2026. The full notice also covers non-peptide products. “Out of specification” means a product did not meet a required specification; the notice does not assign the same failure to every lot.

The 2019 KRS and Pharm D Solutions announcements contain longer product-and-lot lists. Check those full notices for a particular blend. The Pharm D announcement now states that its recall was completed and FDA terminated it.

Do semaglutide and tirzepatide recalls cover every brand or pharmacy?

No. The four recent supplier actions in this register name particular firms, products, or API batches. New Life Pharma, ProRx, Boothwyn, and Harbin Jixianglong had different product scopes. None of those notices, by itself, establishes that every semaglutide or tirzepatide product was recalled.

For ProRx, FDA names tirzepatide lot PRORX08062025-3, plus various semaglutide lots, in its account of the October 15, 2025 recall. For Harbin, FDA identifies semaglutide API batches CP-030-20250711 and CP-030-20250911. Those API batch numbers should not be treated as consumer vial lot numbers. FDA source 3 FDA source 2

For Boothwyn, FDA confirms a July 9, 2025 recall covering unexpired drugs with results outside specifications and related lots or sublots filled from the same bulk stock. The letter describes low-strength semaglutide and tirzepatide examples and a tirzepatide combination that failed sterility testing. Some lot details are redacted, so that letter cannot serve as a complete patient lot list. The API records below supply a separate set of confirmed semaglutide codes. FDA source 5

Which ProRx and Boothwyn lots can be checked directly?

The FDA API supplies seven ProRx product records and three Boothwyn semaglutide records with full code information for these dates. These supplement the letters; they are not extra actions added to the main register. All ten product records are Class II and marked Ongoing in the October 7, 2026 snapshot.

Source: the FDA product records linked in each row, retrieved October 14, 2026. The reason is lack of sterility assurance.

Source: the FDA product records linked in each row, retrieved October 14, 2026. The reason is subpotency, or less drug than the labeled strength.

The Boothwyn API codes are different from the partly redacted inspection examples in its later letter. Keep those sources separate. The recorded best-use dates are historical: a database status of Ongoing does not mean those lots remain unexpired or are still on sale. The >full lot-record download preserves descriptions, dates, and original code strings.

A pharmacy name, exact product, strength, and lot are needed to check a match. A notice about an unapproved or compounded vial also does not establish a recall of Ozempic, Wegovy, Mounjaro, or Zepbound.

Can manufactured prescription peptide drugs also be recalled?

Yes. Four selected 2026 FDA records below cover glucagon, liraglutide, octreotide, and lanreotide products. All four are Class II and marked Ongoing in the October 7, 2026 API snapshot. They are separate examples, outside the ten-action register above, and do not represent every product in their broader events.

Sources: individual FDA records linked in the final column, retrieved October 14, 2026. The full product descriptions, package codes, lot lists, application annotations, and date fields are in the >prescription-drug CSV. A table summary is not enough to decide whether a package is affected.

Are collagen peptide recalls the same as injectable peptide recalls?

No. FDA’s Vital Proteins record concerns an oral collagen product, not an injectable drug. Recall F-0969-2023 identifies a 24-ounce Collagen Peptides canister, batch 30095993HA, with the printed best-by code 01-09-2028. The recall began April 21, 2023 because pieces from a broken blue lid might be present.

Source: FDA food enforcement record F-0969-2023, retrieved October 14, 2026. This food record is excluded from the main drug-action register. The best-by code is reproduced as printed, without changing its date format.

Is an FDA peptide warning letter a recall?

A warning letter alone does not establish a recall. FDA uses warning letters to notify firms of significant violations and seek corrections. A letter can also describe an earlier recall, as the New Life Pharma and ProRx letters do. In that case, the explicit recall statement is the evidence for inclusion. FDA warning-letter guidance.

Sources: FDA recall definitions, Enforcement Reports, and warning-letter guidance. A product can raise safety or regulatory concerns without appearing in this selected recall dataset.

How do I check whether my peptide product matches a recall?

Compare the exact product, firm, strength or package, lot code, and expiry or date code against the original notice. An ingredient name alone cannot establish a match. Start with FDA Enforcement Reports and the company, pharmacy, or clinician that supplied the product.

1. Read the label for the dispensing pharmacy or manufacturer. A clinic’s name may differ from the firm that made the product.
2. Copy the full lot or batch code, including spaces, prefixes, and punctuation. Note the strength, vial size, and any printed expiry or beyond-use date.
3. Search FDA by product and firm. Also check the source’s scope wording: some records say all lots within expiry, while others name specific lots.
4. Follow the original notice’s instructions and contact the supplier or your pharmacist or prescriber promptly about an affected medicine. If you have symptoms or a suspected adverse reaction, contact a health professional and report the problem to FDA.

Source: FDA 101: Product Recalls. This page supplies a source register, not a personal product clearance decision.

What if I cannot find my product in the list?

No matching entry means only that the product is not in this selected dataset. It does not establish that the product has never been recalled, is FDA-approved, or is safe. FDA says compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, and quality before marketing. FDA compounding questions and answers.

FDA also warns about unapproved GLP-1 products sold with research-use labels. Check the agency’s current concerns about unapproved GLP-1 drugs when the issue is a seller’s claims or product quality rather than a named recall.

How was this peptide recalls register built?

We reviewed FDA sources on October 14, 2026 and assembled ten selected drug-related recall actions from 2019–2026. We also retrieved the full GenoGenix event export, ten supplementary ProRx/Boothwyn product records, four manufactured prescription-drug records, and one separate collagen food record. The API responses identify October 7, 2026 as their last update date.

The selection focuses on commonly searched research and compounded peptides, GLP-1 products, and the difference between drug and collagen recalls. It is a reference collection, not a statistical sample or a census of all peptide medicines.

What was counted?

The main table counts an action once per firm and recall or announcement date, using a source that explicitly confirms a recall. Two separate Innoveix dates stay separate. A warning letter and an announcement describing the same action would not create two rows.

For GenoGenix, the full query returned 57 distinct recall numbers with one event ID, 97369. We preserved every returned row, including non-peptide drugs. The detailed public table selects 11 named peptide product records; it does not claim to classify every chemical in the event. FDA explains that one event can include more than one recalled product. FDA field definitions.

How can someone reproduce it?

Open each source in the action CSV and confirm the firm, date type, affected scope, and reason. For GenoGenix, run the event query, confirm the returned total, then count distinct recall_number and event_id values. Compare each selected product’s code_info with Table 2. The JSON snapshot and full CSV preserve the data used here.

The action CSV keeps dates for initiation, announcement, FDA publication, and the supporting document separate. Blank date fields mean the reviewed source did not supply that date. Missing lot lists, redactions, and unverified statuses remain visible.

What does the register leave out?

It does not cover every FDA-approved peptide medicine, all food or cosmetic peptides, every compounding facility, or recalls outside the United States. It does not measure a supplier’s defect rate, the share of unsafe vials, or the chance that a patient will be harmed.

Lack of sterility assurance is not proof that each vial was contaminated. A broad facility recall is not a molecule-wide prohibition. Missing adverse-event reports in an old announcement are not proof that nobody was ever harmed.

FDA’s public announcements page does not list every recall and moves older notices to its archive after three years. Enforcement Reports provide broader recall coverage, including some entries before classification. That is why this page links to both source types. Public notices · Enforcement Reports.

How can I cite or download this page?

For a specific lot or company instruction, cite the original FDA record. For the assembled register or the event-versus-product crosswalk, cite this page and state its scope.

Ready-to-copy citation:

Peptide Care Index. Peptide recalls: FDA records and affected lots. Selected U.S. recall register, compiled October 14, 2026. https://peptidecareindex.com/research/peptide-recalls/. Ten selected drug-related actions, 2019–2026; separate prescription and collagen examples. API status snapshot: October 7, 2026.

You may reuse the original table arrangement and summaries with credit to “Peptide Recall Register.” Preserve FDA attribution and any underlying source terms. This reuse note does not grant rights to third-party logos, photographs, or company material.

Download the data without an account:

• >Ten-action register CSV
• >Selected GenoGenix peptide product records CSV
• >All 57 GenoGenix product records CSV, including non-peptides
• >Original GenoGenix API response snapshot
• >Additional ProRx and Boothwyn lot records CSV
• >Manufactured prescription-drug examples CSV
• >Separate collagen recall example CSV

The >data field guide explains units, date fields, and coverage. What changed: this first compilation was prepared October 14, 2026.

What else should I know about peptide recalls?

Does Class II mean the product is safe to use?

No. Class II is an FDA recall hazard category. It covers situations where exposure may cause temporary or medically reversible harm, or where the chance of serious harm is remote. Follow the product-specific instructions. FDA classifications.

Does a terminated recall mean the ingredient was approved?

No. “Terminated” describes FDA’s conclusion about the recall’s removal or correction efforts and product disposition. It does not establish approval of the ingredient or of a different product using it. FDA status definitions.

Was all ipamorelin recalled?

The Innoveix notice here names a sermorelin/ipamorelin product and three specific lots; the Pharm D notice covers a broader set of that firm’s sterile drugs, including ipamorelin products. These records do not establish a recall of every ipamorelin product sold by every supplier. Innoveix · Pharm D.

Can I use this list to rank peptide sellers by safety?

No. The ten-action collection is selected and mixes broad facility actions with narrower product actions. It has no denominator for units sold, batches made, or inspections performed. Raw recall counts cannot supply a fair supplier safety ranking.

Which sources were checked?

All sources below were checked on October 14, 2026. API records used an October 7, 2026 data snapshot. Company notices and FDA letters retain their original dates.

1. FDA, New Life Pharma letter, April 14, 2026; confirms February 25 recall.

2. FDA, Harbin Jixianglong letter, May 1, 2026; confirms February 19 API recall.

3. FDA, ProRx letter, April 7, 2026; confirms October 15, 2025 recall.

4. FDA, GenoGenix letter, January 20, 2026; confirms July 30, 2025 recall.

5. FDA, Boothwyn letter, January 16, 2026; confirms July 9, 2025 recall.

6. FDA-hosted Olympia announcement, March 10, 2022.

7. FDA-hosted Innoveix announcement, July 12, 2021; FDA publication July 13.

8. FDA-hosted Innoveix announcement, October 10, 2019.

9. FDA-hosted KRS Global Biotechnology announcement, September 12, 2019.

10. FDA-hosted Pharm D Solutions announcement, May 23, 2019.

11. FDA, Enforcement Reports and coverage explanation.

12. FDA, Enforcement Report Information and Definitions.

13. FDA, Recalls, Market Withdrawals, and Safety Alerts; archive and coverage notes.

14. FDA, About Warning and Close-Out Letters.

15. FDA, FDA 101: Product Recalls.

16. FDA, Compounding and the FDA: Questions and Answers.

17. FDA, Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.

18. FDA food enforcement record F-0969-2023, Vital Proteins.

19. FDA drug enforcement event 97369, GenoGenix; full export.

20. FDA, Recalls Background and Definitions.

21. FDA drug enforcement record D-0723-2026, Lupin glucagon.

22. FDA drug enforcement record D-0541-2026, Lupin liraglutide.

23. FDA drug enforcement record D-0519-2026, Teva octreotide.

24. FDA drug enforcement record D-0422-2026, Cipla lanreotide.

25. FDA drug enforcement record D-0606-2025, Boothwyn Pharmacy LLC.

26. FDA drug enforcement record D-0608-2025, Boothwyn Pharmacy LLC.

27. FDA drug enforcement record D-0609-2025, Boothwyn Pharmacy LLC.

28. FDA drug enforcement record D-0114-2026, ProRx LLC.

29. FDA drug enforcement record D-0115-2026, ProRx LLC.

30. FDA drug enforcement record D-0116-2026, ProRx LLC.

31. FDA drug enforcement record D-0117-2026, ProRx LLC.

32. FDA drug enforcement record D-0118-2026, ProRx LLC.

33. FDA drug enforcement record D-0119-2026, ProRx LLC.

34. FDA drug enforcement record D-0120-2026, ProRx LLC.

Peptide Recall Register is a source-linked reference collection about selected U.S. peptide-related recalls.