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
Testosterone Gel 1%
Class IIPresence of foreign substance: Presence of Benzene.
Strides Pharma, Inc. · Mar 5, 2025
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen…
Class IIChemical Contamination: This recall has been initiated due to detected trace levels of benzene.
L'Oreal USA · Mar 5, 2025
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
Class IIcGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
L'Oreal USA · Mar 5, 2025
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatmen…
Class IIcGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
L'Oreal USA · Mar 5, 2025
Gabapentin Capsules
Class IIICross Contamination
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2025
Tolterodine Tartrate Extended-Release Capsules
Class IIIFailed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Mar 4, 2025
Gabapentin Capsules
Class IIICross Contamination
SUN PHARMACEUTICAL INDUSTRIES INC · Mar 4, 2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x…
Class IICGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chattem Inc · Mar 4, 2025
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5…
Class IIChemical Contamination: Presence of benzene
Sigan Industries Group Inc. · Feb 28, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Feb 28, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Feb 28, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Breckenridge Pharmaceutical, Inc. · Feb 28, 2025
Carvedilol Tablets USP 6.25 mg
Class IICGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA · Feb 28, 2025
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01)
Class IICGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA · Feb 28, 2025
Carvedilol Tablets USP 12.5 mg
Class IICGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA · Feb 28, 2025
Carvedilol Tablets USP 25 mg
Class IICGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA · Feb 28, 2025
Neupogen (filgrastim) For Injection
Class IIStability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen, Inc. · Feb 27, 2025
Neupogen (filgrastim) For Injection
Class IIStability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Amgen, Inc. · Feb 27, 2025
Prasugrel Tablets
Class IIFailed Dissolution Specifications - low dissolution results
MYLAN PHARMACEUTICALS INC · Feb 25, 2025
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG
Class IIPresence of Foreign Tablets/Capsules.
A-S Medication Solutions LLC · Feb 25, 2025
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Soluti…
Class IIISub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Imprimis NJOF, LLC · Feb 24, 2025
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g)…
Class IIChemical Contamination: Presence of benzene.
Denison Pharmaceuticals, LLC · Feb 24, 2025
Livalo (pitavatstatin) tablets
Class IIIPresence of foreign tablets/capsules
Kowa Pharmaceuticals America · Feb 24, 2025
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsu…
Class IMarketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
One Source Nutrition, Inc, · Feb 20, 2025
PHENYLephrine added to 0.9% sodium chloride
Class IPresence of Particulate Matter
Central Admixture Pharmacy Services, Inc. · Feb 20, 2025
Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe
Class IILack of Assurance of Sterility: due to a quality control process deviation
Turbare Manufacturing · Feb 18, 2025
Simethicone 20 mg per 0.3 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Medline Alcohol Prep Pads
Class IISubpotent Drug
MEDLINE INDUSTRIES, LP - Northfield · Feb 17, 2025
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
CURAD Alcohol Prep Pads
Class IISubpotent Drug
MEDLINE INDUSTRIES, LP - Northfield · Feb 17, 2025
Ergocalciferol
Class IIDefective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Safecor Health, LLC · Feb 17, 2025
BD ChloraPrep Clear 1mL Applicators
Class INon-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
CareFusion 213, LLC · Feb 14, 2025
Nelarabine Injection
Class IIFailed Impurities/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Feb 13, 2025
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%
Class IIChemical Contamination
Johnson, S C and Son, Inc · Feb 13, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
ICU Medical, Inc. · Feb 13, 2025
Nelarabine Injection
Class IIFailed Impurities/Degradation Specifications
Zydus Pharmaceuticals (USA) Inc · Feb 13, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
ICU Medical, Inc. · Feb 13, 2025
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3…
Class IIChemical Contamination
Johnson, S C and Son, Inc · Feb 13, 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.