Recall tracker
Active FDA enforcement actions, safety communications, and supply updates affecting medications we cover. We mirror primary FDA and manufacturer sources and link to them; we do not replace official communications.
Subscribe: RSS feed
Active (7)
- Compounded semaglutide voluntary Class II recall, April 2026Class II recall
Several 503A compounding pharmacies voluntarily recalled compounded semaglutide lots due to potency variability findings.
Announced 2026-04-12 · Compounded semaglutide - FDA safety communication: tirzepatide and thyroid C-cell tumorsSafety communication
FDA reiterated the existing tirzepatide black-box warning for thyroid C-cell tumor risk after a small uptick in MedWatch reports.
Announced 2026-02-20 · Tirzepatide (Zepbound / Mounjaro) - FDA alert: counterfeit Ozempic pens detected in US supply chainSafety communication
FDA warned of counterfeit Ozempic 1 mg pens with fake lot numbers detected at US wholesalers and pharmacies in late 2024.
Announced 2024-12-20 · Ozempic (counterfeit) - FDA warning letters to 30+ compounding pharmacies, July 2025Safety communication
FDA issued warning letters to 30+ 503A and 503B compounding pharmacies offering compounded GLP-1s after the shortage was officially declared resolved.
Announced 2025-07-15 · Compounded semaglutide and tirzepatide - FDA safety communication: Wegovy injection-site reactionsSafety communication
FDA noted increased reports of injection-site reactions with Wegovy and provided refreshed guidance on injection-site rotation and technique.
Announced 2025-03-12 · Wegovy - Compounded tirzepatide voluntary recall, September 2025Class II recall
Multiple compounding pharmacies issued voluntary Class II recalls for compounded tirzepatide due to potency and sterility concerns.
Announced 2025-09-08 · Compounded tirzepatide - FDA safety communication: GLP-1 medications and gastroparesisSafety communication
FDA acknowledged increased reports of gastroparesis (delayed gastric emptying) across all GLP-1 medications and updated provider guidance.
Announced 2024-05-14 · Ozempic, Wegovy, Mounjaro, Zepbound
Resolved
- Wegovy supply normalization (shortage status removed Q4 2025)Resolved
Novo Nordisk announced full Wegovy supply normalization, removing all dose strengths from the FDA Drug Shortage list as of November 2025.
- Saxenda supply disruption resolved (Q4 2024)Resolved
Novo Nordisk restored full Saxenda supply after a 9-month manufacturing disruption tied to semaglutide demand pulling production capacity.
Report an adverse event
Suspected adverse drug events should be reported to the FDA MedWatch program: FDA MedWatch. Reports help identify safety signals that may trigger future regulatory action.
Frequently asked
What's the difference between an FDA recall and a safety communication?+
An FDA recall removes a specific product (lot, batch, or distribution channel) from the market. A safety communication is a warning about a risk that may not require physical removal — for example, an update to prescribing information, a black-box warning, or a Dear Healthcare Provider letter. Recalls are classified Class I (serious health risk), Class II (temporary or reversible adverse health consequence), or Class III (unlikely to cause adverse health consequence).
What should I do if my medication is recalled?+
First: check whether your specific lot number is affected — most recalls target specific batches, not the entire product. The lot number is printed on the box and on the pen or vial label. If your lot is affected, stop using it and contact the dispensing pharmacy for a replacement. If you experienced any adverse effect, report it to FDA MedWatch and to your prescriber. Do not stop a chronic medication abruptly without medical guidance.
Are compounded GLP-1 medications subject to FDA recalls?+
Compounded drugs follow a different oversight framework. 503A compounding pharmacies are regulated primarily by state boards of pharmacy; 503B outsourcing facilities have FDA oversight similar to manufacturers. FDA warning letters and seizure actions affect compounded products, but the recall mechanism is more variable. Many compounded GLP-1 quality issues surface through state board actions or DOJ enforcement rather than classical FDA recalls.
Where can I report a suspected drug problem?+
FDA MedWatch: fda.gov/medwatch or 1-800-FDA-1088. This is the federal reporting system for adverse events, product quality problems, and therapeutic failures. You can report as a consumer or as a healthcare professional. Reports are reviewed and feed into FDA's safety surveillance system; they directly influence whether a regulatory action is taken.
How does glpzoom track recalls?+
We monitor FDA enforcement reports, MedWatch safety communications, manufacturer press releases, and state board actions for the medications and platforms we cover. Each recall page documents the lot scope, regulatory action, manufacturer response, and patient impact, with primary-source links. Subscribe to /recalls/feed.xml for an RSS feed of new entries.