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
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…
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
DOBUTamine Injection
Class IIDiscoloration; discolored solution from cracked vials
Pfizer Inc. · May 28, 2025
Azelastine HCl Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · May 28, 2025
Ketorolac Tromethamine Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · May 28, 2025
Fluoxetine Tablets
Class IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma Inc. · May 27, 2025
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Medical Care Holdings, Inc. · May 27, 2025
Fluoxetine Tablets
Class IICGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Torrent Pharma Inc. · May 27, 2025
Cephalexin for Oral Suspension
Class IIFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Ascend Laboratories, LLC · May 23, 2025
Spectrum Advanced Gel Hand Sanitizer
Class IISubpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Consumer Product Partners, LLC · May 23, 2025
Cephalexin for Oral Suspension
Class IIFailed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Ascend Laboratories, LLC · May 23, 2025
Metoclopramide Tablets
Class IIPresence of foreign tablets/capsules.
Teva Pharmaceuticals USA, Inc · May 23, 2025
Acetaminophen Tablets
Class IIcGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Aurobindo Pharma USA Inc · May 22, 2025
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Tirzepatide Injections
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Semaglutide/Cyanocobalamin Injectable
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
LL Bioboost Injectable
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
LX Bioboost Plus
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Showing 40 of 1,576 Class II recalls (1,895 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.