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
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
CJC-1295 Injectable
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Invernes…
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Tirzepatide/Cyanocobalamin Injectable
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
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
Methylcobalamin Injectable
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
Tirzepatide/Cyanocobalamin Injectable
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, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness,…
Class IILack of Assurance of Sterility
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · May 21, 2025
BD ChloraPrep Clear
Class IILack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
CareFusion 213, LLC · May 15, 2025
Theophylline (Anhydrous) Extended-Release Tablets
Class IIOOS results reported for the Dissolution (by UV) test.
Glenmark Pharmaceuticals Inc., USA · May 15, 2025
Indomethacin Extended-Release Capsules
Class IIcGMP deviations
Amerisource Health Services LLC · May 15, 2025
Airsupra (albuterol and budesonide) inhalation aerosol
Class IIDefective delivery system
AsttraZeneca Pharmaceuticals LP · May 14, 2025
Celecoxib Capsules
Class IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
AvKARE · May 13, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Class IIFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
Phentermine Hydrochloride Capsules
Class IIcGMP deviations
KVK Tech, Inc. · May 9, 2025
Celecoxib Capsules
Class IIPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Alembic Pharmaceuticals Limited · May 9, 2025
Indomethacin Extended-Release Capsules USP
Class IIcGMP deviations
KVK Tech, Inc. · May 9, 2025
Chlorthalidone Tablets
Class IIFailed Dissolution Specifications
AvKARE · May 9, 2025
Bromfenac Ophthalmic Solution 0.09%
Class IIFailed Impurities/Degradation Specifications
Alembic Pharmaceuticals Limited · May 7, 2025
Testosterone Cypionate Injection
Class IILack of Assurance of Sterility
Empower Clinic Services, LLC dba Empower Pharmacy · May 2, 2025
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 28, 2025
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%)
Class IIPresence of Particulate Matter: Glass particles were found in pellet vials.
BSO LLC · Apr 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.