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
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 mg/100 mL…
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…
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…
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…
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…
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…
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 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…
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 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…
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
Showing 40 of 1,903 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.