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
Ranolazine Extended-Release Tablets 1000mg
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
Cetirizine Hydrochloride Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Mar 13, 2025
In Your Face Mineral Tint SPF 31
Class IIcGMP deviations
KABANA SKIN CARE · Mar 12, 2025
Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%)
Class IIChemical contamination: Presence of benzene
Alchemee, LLC · Mar 12, 2025
B Natural Organics
Class IIcGMP deviations
KABANA SKIN CARE · Mar 12, 2025
Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%)
Class IIChemical contamination: Presence of benzene
Alchemee, LLC · Mar 12, 2025
Erin's Faces
Class IIcGMP deviations
KABANA SKIN CARE · Mar 12, 2025
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunsc…
Class IIcGMP deviations
KABANA SKIN CARE · Mar 12, 2025
chlorproMAZINE Hydrochloride Tablets
Class IICGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Glenmark Pharmaceuticals Inc., USA · Mar 11, 2025
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne…
Class IIChemical contamination: presence of benzene
Fruit Of The Earth, Inc. · Mar 11, 2025
Ciprofloxacin Ophthalmic Solution USP
Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Mar 11, 2025
CVS Health Concealing Acne Treatment Cream
Class IIChemical contamination: presence of benzene
Fruit Of The Earth, Inc. · Mar 11, 2025
Duloxetine D/R
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx · Mar 7, 2025
Cinacalcet Hydrochloride Tablets 30 mg
Class IICGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Slate Run Pharmaceuticals · Mar 7, 2025
Levothyroxine Sodium Tablets
Class IISuper-Potent Drug: Out of specification potency results were obtained.
Mylan Institutional, Inc. · Mar 7, 2025
Cinacalcet Hydrochloride Tablets 60 mg
Class IICGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Slate Run Pharmaceuticals · Mar 7, 2025
Levothyroxine Sodium Tablets
Class IISuper-Potent Drug: Out of specification potency results were obtained.
Mylan Institutional, Inc. · Mar 7, 2025
8.4% Sodium Bicarbonate Injection
Class IILack of Assurance of Sterility
Exela Pharma Sciences LLC · Mar 7, 2025
[CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution
Class IILabeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Consumer Product Partners, LLC · Mar 7, 2025
Duloxetine D/R
Class IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Direct Rx · Mar 7, 2025
Sofosbuvir and Velpatasvir
Class IIDefective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
ASEGUA THERAPEUTICS LLC · Mar 7, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 m…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Mar 6, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 m…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Mar 6, 2025
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100…
Class IILack of Assurance of Sterility
QuVa Pharma, Inc. · Mar 6, 2025
Testosterone Gel 1%
Class IIPresence of foreign substance: Presence of Benzene.
Strides Pharma, Inc. · Mar 5, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Mar 5, 2025
PRASUGREL TABLETS
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Mar 5, 2025
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
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
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.