--- title: "Where Your GLP-1 Lot Number Lives, and Why It Matters | Peptyn" description: "Where to find your semaglutide or tirzepatide lot number, and how to check it against FDA recall and counterfeit notices." canonical: "https://peptyn.orlyn.ai/articles/glp1-recall-lot-number" last-updated: "2026-08-16" --- # Your GLP-1 lot number: where to find it, and how to check it against an FDA recall *Where to find your semaglutide or tirzepatide lot number, and how to check it against FDA recall and counterfeit notices.* Educational · Not medical advice · 18+ A lot number is a short alphanumeric code printed on your vial, pen, or carton. It identifies the manufacturing batch that particular unit came from. Most of the time you will never think about it. On the day a recall or counterfeit notice names a batch, it is the only line on your record that answers the question you actually have, which is whether the notice is about you. Published 15 August 2026 · 11 min read · 11 sources ## Where to find the lot number On a pen, the lot number appears on the pen's own label and again on the outer carton, next to the expiration date. The two are usually printed as a pair under an `EXP` / `LOT` heading. They are different things: the expiration date tells you when shelf life ends, the lot number tells you which production run the unit came from. That pairing is worth looking at closely rather than skimming. In its December 2025 counterfeit notice, the FDA said the counterfeit pens it had seized could be identified by the position of the `EXP/LOT` text on the pen's label: on the authentic pen that text sits above the expiration date and lot number, and on those counterfeits it sits to the left of them.[4] That tell was specific to the units in that notice. It is not a general test of authenticity, and the rest of this page depends on the difference. On a multi-dose vial, the lot is printed on the label on the vial itself and repeated on the outer packaging. On a carton, it is generally on a side panel or the bottom flap. The practical point: **write the lot number down when the package arrives.** Once the carton is in the recycling, the number is gone. If a recall notice appears three weeks later, you cannot check what you no longer have. ## The recalls are real, and the scope varies Recalls of compounded GLP-1 products are not hypothetical. Two documented examples, both taken from FDA warning letters: - On **October 15, 2025**, ProRx LLC initiated a voluntary recall of a lot of Tirzepatide Injection in multidose vials, along with various lots of Semaglutide Injection in multidose vials, all within expiry, **due to a lack of sterility assurance**. The recalled tirzepatide lot was identified as `PRORX08062025-3`.[5] - On **July 30, 2025**, GenoGenix LLC initiated a voluntary recall of drug products intended or expected to be sterile, within expiry, **due to lack of sterility assurance or microbial contamination**. The firm had repackaged products including semaglutide and tirzepatide.[6] Now notice what those two summaries do not tell you, because it is the reason this article keeps sending you to the Enforcement Report rather than to the warning letter. A warning letter summarises. "Various lots of Semaglutide Injection" and "drug products intended or expected to be sterile" are the agency describing a recall in passing, in a document written about something else. The Enforcement Report enumerates. Open the same two events there and every lot is spelled out: the ProRx semaglutide records list codes one by one, and the GenoGenix event lists its semaglutide under `GG021125-001` and `GG031125-017`, its tirzepatide under `GG012925-005` and `GG021125-003`, and its retatrutide under `GG021125-019`.[2] Both events are classified Class II, and both were initiated by the firm. Scope does still vary, and it varies inside a single event rather than between them. In that same GenoGenix action the plain semaglutide vials are limited to two named lots, while the semaglutide-with-B12 presentation is recalled as "All lots within expiry."[2] Two products, one firm, one date, two different answers to "does my code matter." That is the reason to read the record for the exact presentation you hold rather than the headline for the firm. So record the lot, but expect to need the rest of the entry too. Product description, firm name, and dates do work the lot number cannot do alone. What is true in both cases is that if you recorded nothing, you cannot answer the narrow version of the question, and nobody can answer it on your behalf without pulling your dispensing records. Note also who acted. In both cases the **firm** initiated the recall, not the agency. The FDA is direct about this being the norm: a drug recall "is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk."[1] Firms recall voluntarily, sometimes on their own initiative and sometimes after an FDA inspection or request, and the FDA then classifies and publishes the action. Enforcement records carry a Voluntary/Mandated field for exactly this, with "mandated" reserved for recalls initiated under a statutory recall authority, a court order, or an FDA order.[3] ## Counterfeits reuse real lot numbers This is the part that most articles get backwards, so it is worth being exact about. The FDA has issued repeated notices about counterfeit Ozempic entering the **legitimate U.S. drug supply chain**, not just informal or grey channels: - **December 2023:** counterfeit Ozempic labeled with lot `NAR0074` and serial number `430834149057`. Thousands of units were seized. Analysis confirmed the needles were counterfeit, so their sterility could not be confirmed. - **April 2025:** counterfeit units labeled with lot `PAR0362`. - **December 2025:** counterfeit units labeled with lot `PAR1229`. In the December 2025 notice the FDA stated plainly that `PAR1229` "**also is an authentic lot number**", and that patients who received Ozempic with that lot through the Novo Nordisk Patient Assistance Program could continue using it because their product was authentic.[4] The lesson is the opposite of the folk wisdom. You cannot detect a counterfeit by deciding a lot number "looks wrong" or does not match some imagined manufacturer numbering pattern. Counterfeiters copy genuine codes. The lot number tells you which notice to read; it does not certify anything by itself. ## How to check a lot number against FDA records There are two places to look, and they do different jobs. **1. The Drug Recalls list.** The FDA publishes a table of drug recalls at fda.gov/drugs/drug-safety-and-availability/drug-recalls.[1] It is a searchable table with columns for date, brand name, product description, recall reason, and company name, plus a filter for whether a recall has been terminated. Search it for `semaglutide`, `tirzepatide`, or a brand or company name. This list is built from public recall announcements, so it is the faster read when a headline sends you looking. **2. The Enforcement Report.** The FDA's formal recall record lives at fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports, published as a **weekly** report with a separate search interface over past entries.[2] This is the database that carries the batch-level detail. Its advanced search filters on product description, code information, product type, recall class, recalling firm, status, recall number, reason for recall, and classification date, among others. The one that matters here is **code information**, which the FDA defines as "a list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling." That is the field your written-down number gets compared against. Read the fields around it too, because they answer the follow-up questions. Recall initiation date is when the firm first began notifying the public or its consignees. Distribution pattern is the general area of initial distribution, with the caveat that onward distribution by those consignees may not be captured. Status tells you whether the action is on-going, completed, or terminated. What the record does not carry is any way to reach a person about your specific unit. There is no consumer contact field, because the report is a regulatory publication rather than a help desk. If a recall looks like it covers you, the next call is to the pharmacy or prescriber that supplied the product. ### Reading the classification correctly Recall classes are frequently described backwards. The FDA's definitions run in the opposite direction from what the numbering suggests: - **Class I** is the most serious: a reasonable probability that use of the product will cause serious adverse health consequences or death. - **Class II**: use may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. - **Class III** is the least serious: use is not likely to cause adverse health consequences. Entries may also appear as "Not Yet Classified", because classification usually happens after the recalling firm supplies the information the FDA needs. A recall you read about the week it is announced may not have a class attached yet.[3] So Class I is the urgent one. A lower number means higher severity. ### A published entry can change later This is the part that makes a single check less conclusive than it feels. The Enforcement Report tracks updates to a recall's product description, reason for recall, classification, and **code information**. Records changed in the last seven days are flagged in a "Recently Updated Record" column, and each entry carries an Update History section naming the field that changed, the date, and the previous and new values. If code information has been modified three times, all three changes are shown.[7] Read that field list again: code information is one of the things that gets revised. A lot list can be extended after the recall is first posted, as a firm works out how far a problem reached. Checking once, the week a headline lands, and concluding your batch is clear is a weaker answer than it feels like, and classification can arrive later too. You do not have to keep checking by hand. The Enforcement Report offers an email subscription that supports keyword alerts, and the FDA notes those keywords can be product-specific or based on the reason for recall, giving "sterility" as one of its own examples. A standing subscription on a compound name does the watching for you.[2] ## Reporting a problem, and to which channel There are two routes, and they are not interchangeable. **A problem with the product.** MedWatch is the FDA's program for reporting serious reactions, product quality problems, therapeutic inequivalence or failure, and product use errors with human medical products.[8] Patients and consumers can file directly. The FDA suggests taking the form to your doctor so clinical detail from your record can be included, while also stating plainly that a provider is not required to report and that you may complete the form yourself.[9] **A product you suspect is counterfeit.** That is a different channel. In its counterfeit Ozempic notice, the FDA directs suspected counterfeits to a local FDA consumer complaint coordinator or to its Office of Criminal Investigations, not to MedWatch.[4][10] Include the lot number either way. The agency's own notices are written at lot level: in both the April and December 2025 counterfeit updates it reported how many adverse event reports it had received "associated with this lot", and whether those reports traced to the authentic product or the counterfeit one. A report carrying a lot number can be sorted that way. One without a lot number cannot. ## What a lot number cannot do It cannot tell you a product is safe. A batch with no recall against it has not been proven fine; it has simply never been the subject of a published action. A batch that has been recalled will contain many units that would never have harmed anyone, because recalls are precautionary responses to testing and process failures, not to confirmed injury in every recipient. "Lack of sterility assurance", the reason given in both recalls above, means the process could not be shown to guarantee sterility, not that every vial was contaminated. It is also not a customer service question. Calling a vendor to ask whether "lot X is safe" produces an answer with no independent weight behind it, and searching forums for a lot number produces anecdotes of unknown reliability. Use the number to check the FDA's published record. If you have a concern about a specific unit, take the number to your prescriber or pharmacist, who can check dispensing records and supplier notices you cannot see. What it can do is answer one narrow question quickly and definitively: is the batch in this notice the batch in my hand. ## Building a record you can actually use Whatever you track with, a spreadsheet, a paper notebook, or an app, the lot number belongs next to the date and the compound. An entry that reads `Semaglutide, vial opened Tue 12 Aug, lot \[as printed on carton\]` is checkable against any notice that later appears. A half-remembered "I think that vial came in around July" is not. Most trackers, including Peptyn, do not have a dedicated lot number field, and Peptyn has no free-text field to put one in either. Keep the carton, or a photograph of it, alongside whatever you log in. It takes a few seconds at the moment a package arrives and never needs touching again unless something happens. If you keep records by hand, a table with columns for Date, Compound, Lot, and Notes does the same work. The one habit that matters: record it **on arrival**, from the carton, before the carton is thrown away. ## If you use compounded formulations The same practice applies, with one wrinkle. Compounded products are not FDA-approved, though the facilities that make them are subject to FDA inspection, and their recalls are published in the same enforcement records as everything else. The FDA maintains a dedicated page for compounding inspections, recalls, and other actions.[11] That page is worth knowing about for a reason beyond recalls. It is an A to Z list of named facilities, marking each as a 503A or 503B operation and noting where one has ceased compounding or de-registered, with the inspection findings and letters issued to it linked underneath. If you know the name of the pharmacy that supplied you, you can look up its regulatory history directly rather than inferring it. The page also links through to the Enforcement Report, though as a plain link rather than a search narrowed to compounders, so you still do the filtering yourself. The batch identifier may come from the compounding pharmacy rather than a manufacturer, and the formats vary. The real ProRx lot cited above, `PRORX08062025-3`, is a date-based code with a sequence suffix. Others use plain sequential numbering. The format carries no information about quality. Record whatever is on the label, exactly as printed, including any prefixes and hyphens, because that is the string an enforcement record will be matched against. ## What this is worth Lot-number tracking is unremarkable most of the time and occasionally the only thing that answers the question in front of you. That occasion may never arrive. If it does, the work involved was writing down one code from a box you were already holding. Keeping records is not a medical decision, and looking up a published FDA notice is not one either. Both are ordinary document-keeping, and they fit alongside [the other fields worth logging](https://peptyn.orlyn.ai/articles/glp1-tracker-spreadsheet). ## References 1. FDA. Drug Recalls. 2. FDA. Enforcement Reports. 3. FDA. Enforcement Report Information and Definitions (recall classifications). 4. FDA. Warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain. Updated December 5, 2025. 5. FDA. Warning Letter, ProRx LLC, MARCS-CMS 723704, April 7, 2026. 6. FDA. Warning Letter, GenoGenix LLC, MARCS-CMS 718739, January 20, 2026. 7. FDA. Enforcement Report History Feature (tracked updates to classification, reason for recall, and code information). 8. FDA. MedWatch: FDA Safety Information and Adverse Event Reporting Program. 9. FDA. Reporting Serious Problems to FDA (MedWatch scope and who may file). 10. FDA. Consumer Complaint Coordinators (channel for suspected counterfeits). 11. FDA. Compounding: Inspections, Recalls, and other Actions. ## Keep reading - [The 28-day rule, and when it applies](https://peptyn.orlyn.ai/articles/28-day-rule-glp1-vial) Where the number comes from in USP 797, why most GLP-1 labels set a different one, and which date only you can record. - [Compounded GLP-1s: the 2026 timeline](https://peptyn.orlyn.ai/articles/compounded-glp1-2026-regulatory-changes) Every date traced to an FDA or Federal Register document, and why your own log is what carries across a formulation change. - [The GLP-1 tracking spreadsheet: eight fields that matter](https://peptyn.orlyn.ai/articles/glp1-tracker-spreadsheet) The eight columns worth keeping, what each one answers months later, and the three moments a spreadsheet stops being the right tool. - [Who can actually see your GLP-1 data](https://peptyn.orlyn.ai/articles/glp1-app-data-privacy) What HIPAA does not cover, which law applies instead, and a checkable method for reading any app's privacy label. This article is educational. It does not recommend doses, schedules, or products, and it is not medical advice. Every factual claim above is linked to its source. Questions about your own protocol belong with the prescriber who wrote it. --- Source: