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
Clorazepate Dipotassium Tablets
Class IIDiscoloration: Dotted and yellow spots on tablets
Aurobindo Pharma USA Inc. · Apr 24, 2024
Clorazepate Dipotassium Tablets
Class IIDiscoloration: Dotted and yellow spots on tablets
Aurobindo Pharma USA Inc. · Apr 24, 2024
Haloperidol decanoate Injection 50mg/mL
Class IIPresence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
SOMERSET THERAPEUTICS LLC · Apr 24, 2024
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted)
Class IIPresence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Lupin Pharmaceuticals Inc. · Apr 24, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution)…
Class IILack of Assurance of Sterility: Complaints of syringe breakage
Regeneron Pharmaceuticals Inc · Apr 23, 2024
Cloderm (clocortolone pivalate) Cream
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
minolira (minocycline hydrochloride) extended-release tablets
Class IICGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
EPI Health, LLC · Apr 23, 2024
Schwinnng Herbal Dietary Supplement Capsules
Class IMarketed Without An Approved NDA/ANDA
Stop Clopez Corp · Apr 22, 2024
Xelpros (latanoprost ophthalmic emulsion) 0.005%
Class IIIFailed Release Testing: Out of specification for particulate matter test.
SUN PHARMACEUTICAL INDUSTRIES INC · Apr 22, 2024
Tirzepatide 10 mg/0.5 mL Sterile Solution
Class ILabeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Revive Rx LLC dba Revive Rx Pharmacy · Apr 20, 2024
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg 300 per…
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
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Rx Only, 100…
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
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile per carton…
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
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Rx Only, a) 100 per…
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 50 with Water Armor Tech
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic (Camphor 3%, Menthol 3%)…
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%…
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%…
Class IIOut of Specification for active ingredient
ARG Laboratories, Inc. · Apr 17, 2024
Pain Wizard, Natural Relief for Muscular & Arthritic (Camphor 3%, Menthol 3%)…
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 (Camphor 3%, Menthol 3%)…
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 (Camphor 3%, Menthol 3%)…
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 Preservative-Free
Class IIIOut of specification for assay
Imprimis NJOF, LLC · Apr 10, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic…
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…
Class IICGMP Deviations
HONEYWELL INC · Mar 29, 2024
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.