FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
Omeprazole Delayed-release Capsules
Class IIPresence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Dr. Reddy's Laboratories, Inc. · Jun 30, 2025
Budesonide Inhalation Suspension
Class IILack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Cipla USA, Inc. · Jun 30, 2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg
Class IIFailed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Lupin Pharmaceuticals Inc. · Jun 27, 2025
Buffered Penicillin G Potassium for Injection
Class ILabeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Sandoz Inc · Jun 27, 2025
Cefazolin for Injection
Class ILabeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Sandoz Inc · Jun 27, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jun 26, 2025
Pitavastatin Tablets
Class IIIFailed Impurity/Degradation Specifications
AvKARE · Jun 26, 2025
Metoprolol Succinate Extended-Release Tablets
Class IIFailed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Granules Pharmaceuticals Inc. · Jun 24, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Levothyroxine Sodium Tablets
Class IISubpotent Drug: Assay below the approved specification
ACCORD HEALTHCARE, INC. · Jun 20, 2025
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Class IIProduct Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Lupin Pharmaceuticals Inc. · Jun 20, 2025
Gabapentin Capsules
Class IIDefective container; blister packaging inadequately sealed.
The Harvard Drug Group LLC · Jun 19, 2025
Gabapentin Capsules
Class IIDefective container; blister packaging inadequately sealed.
The Harvard Drug Group LLC · Jun 19, 2025
0.9% Sodium Chloride Injection USP
Class IILack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
B BRAUN MEDICAL INC · Jun 16, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
SUN PHARMACEUTICAL INDUSTRIES INC · Jun 16, 2025
Testosterone 200 mg Pellet packaged in 1mL amber vials
Class IIILabeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Qualgen, LLC · Jun 16, 2025
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jun 11, 2025
Famciclovir Tablets
Class IIIPresence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Macleods Pharmaceuticals Ltd · Jun 11, 2025
Pitavastatin Tablets
Class IIIFailed Impurities/Degradation Specifications.
Orient Pharma Co., Ltd. Yunlin Plant · Jun 11, 2025
KIMMTRAK (tebentafusp-tebn) Injection
Class IISubpotent Drug
IMMUNOCORE, LLC · Jun 10, 2025
ZICAM NASAL ALLCLEAR
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Church & Dwight Inc · Jun 6, 2025
ZICAM COLD REMEDY MEDICATED NASAL SWABS
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Church & Dwight Inc · Jun 6, 2025
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.…
Class IMicrobial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Church & Dwight Inc · Jun 6, 2025
LIDOcaine HCL Sterile Injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
Sulfamethoxazole and Trimethoprim Tablets
Class IMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Amneal Pharmaceuticals, LLC · Jun 2, 2025
LIDOcaine HCl Injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
BUPIVAcaine HCL Sterile injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
KETAmine Hydrochloride Injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
LIDOcaine HCL Sterile Injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
KETAmine Hydrochloride Injection
Class IILack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Tailstorm Health INC · Jun 2, 2025
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml mul…
Class IIMarketed Without an Approved NDA/ANDA
Advanced Pharmaceutical Technology, Inc. · May 30, 2025
Icosapent Ethyl Capsules 1 gram
Class IIFailed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Zydus Pharmaceuticals (USA) Inc · May 30, 2025
Levothyroxine Sodium Tablets
Class IIIPresence of a foreign substance: black hair found embedded in tablet.
Macleods Pharmaceuticals Ltd · May 29, 2025
Gentamicin Injection
Class IIFailed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Eugia US LLC · May 29, 2025
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · May 28, 2025
Showing 40 of 1,769 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.