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
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide + Cyanocobalamin injection solution
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol
Class IILack of Processing Controls.
AEQUITA PHARMACY · Jul 18, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceutical, Inc. · Jul 15, 2025
Sucralfate Tablets
Class IICGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Nostrum Laboratories, Inc. · Jul 11, 2025
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Bicillin L-A (penicillin G benzathine injectable suspension)
Class IICGMP Deviations; particulates identified during visual inspection
Pfizer Inc. · Jul 10, 2025
Beauty & Skincare Power Stick original nourishing invisible protection roll-on…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Bicillin L-A (penicllin G benzathine injectable suspension)
Class IICGMP Deviations; particulates identified during visual inspection
Pfizer Inc. · Jul 10, 2025
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder…
Class IICGMP Deviations
A.P. Deauville, LLC · Jul 10, 2025
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Class IISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
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
Cinacalcet Tablets 90 mg
Class IIFailed Dissolution Specifications.
Strides Pharma, Inc. · Jul 9, 2025
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Class IISubpotent Drug
Boothwyn Pharmacy LLC · Jul 9, 2025
Epinephrine Lidocaine HCL
Class IISub-Potent Drug: Subpotent assay results during stability testing.
Imprimis NJOF, LLC · Jul 9, 2025
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 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 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
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.