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
Rizatriptan Benzoate Tablets
Class IICGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Ascend Laboratories, LLC · Jul 9, 2025
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Class IISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with…
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
RITE AID PHARMACY
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
Medline Alcohol Prep Pads
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walmart…
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
CURAD Alcohol Prep Pads
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
Good Neighbor Pharmacy
Class IISubpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield · Jul 7, 2025
Timolol Maleate Ophthalmic Solution USP
Class IIDefective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
FDC Limited · Jul 5, 2025
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Class IILabeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lupin Pharmaceuticals Inc. · Jul 2, 2025
PERIPHERAL PARENTERAL NUTRITION
Class IILack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles · Jul 1, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Breckenridge Pharmaceutical, Inc. · Jun 30, 2025
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
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
KIMMTRAK (tebentafusp-tebn) Injection
Class IISubpotent Drug
IMMUNOCORE, LLC · Jun 10, 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
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
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
Lacosamide Oral Solution
Class IIDefective Container: This recall is being initiated due to a leaking unit stored horizontally.
Apotex Corp. · May 28, 2025
Showing 40 of 1,472 Class II recalls (1,769 tracked in total).
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.