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
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Onl…
Class IIFailed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Nomax Inc · Apr 19, 2024
Amphotericin B Liposome for Injection
Class IIOut of specification for assay
SUN PHARMACEUTICAL INDUSTRIES INC · Apr 19, 2024
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tec…
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIFailed Dissolution Specifications
Glenmark Pharmaceuticals Inc., USA · Apr 17, 2024
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl S…
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl S…
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
NATURAL PAIN RELIEVING CREAM
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol…
Class IIOut of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
ARG Laboratories, Inc. · Apr 17, 2024
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars
Class IIcGMP Deviations
Dercher Enterprises, Inc., DBA Gordon Laboratories · Apr 12, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Class IIIOut of specification for assay
Imprimis NJOF, LLC · Apr 10, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution…
Class IISubpotent Drug
Imprimis NJOF, LLC · Apr 10, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Abilify (aripiprazole)
Class IIICross Contamination with Other Products
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Apr 9, 2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Class ISub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc. · Apr 8, 2024
Cyclophosphamide for Injection
Class IIILabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
X-Gen Pharmaceuticals Inc. · Apr 2, 2024
Cyclophosphamide for Injection
Class IIILabeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
X-Gen Pharmaceuticals Inc. · Apr 2, 2024
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.…
Class IICGMP Deviations
HONEYWELL INC · Mar 29, 2024
Isotretinoin Capsules
Class IISuperpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc · Mar 28, 2024
Atovaquone Oral Suspension USP
Class IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.
AvKARE · Mar 28, 2024
NEXLIZET (bempedoic acid and ezetimibe) tablets
Class IIIFailed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Esperion · Mar 27, 2024
Lansoprazole Delayed-Release Capsules USP
Class IICGMP Deviations
NATCO Pharma Limited · Mar 27, 2024
Diltiazem Hydrochloride Extended-Release Capsules
Class IIFailed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Glenmark Pharmaceuticals Inc., USA · Mar 26, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Class IIShort fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Cipla USA, Inc. · Mar 26, 2024
Digoxin Tablets
Class IIIFailed Impurities/Degradation Specifications
Novitium Pharma LLC · Mar 25, 2024
Methylergonovine Maleate Tablets
Class IIFailed Dissolution Specifications
Amneal Pharmaceuticals of New York, LLC · Mar 25, 2024
Aruba Aloe Hand Sanitizer Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Alcoholada Gel
Class IChemical Contamination: Product manufactured with ethanol API that contains methanol
Aruba Aloe Balm N.V. · Mar 23, 2024
Lactated Ringer's Injection USP
Class IILack of assurance of sterility: bags have the potential to leak..
B. Braun Medical Inc · Mar 22, 2024
fentaNYL Citrate 2
Class IILack of Assurance of Sterility: leaking bags
IntegraDose Compounding Services LLC · Mar 22, 2024
Vancomycin Hydrochloride for Oral Solution
Class ISuperpotent Drug: Due to overfilling of drug powder
Amneal Pharmaceuticals of New York, LLC · Mar 21, 2024
Rifampin Capsules USP
Class IISubpotent Drug
Lupin Pharmaceuticals Inc. · Mar 21, 2024
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.