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
traMADol Hydrochloride Tablets
Class IIPresence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Rubicon Research Private Limited · Apr 26, 2024
MethylPREDNISolone Acetate Injectable Suspension
Class IIPresence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals · Apr 25, 2024
Timolol Maleate Ophthalmic Solution
Class IIDefective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
FDC Limited · Apr 25, 2024
Cefdinir for Oral Suspension USP 125 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
Progesterone 200 mg
Class IIPresence of Foreign Substance; Broken metal piece found embedded in tablet.
Coast Quality Pharmacy, LLC dba Anazao Health · Apr 24, 2024
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
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
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic…
Class IISubpotent Drug
Imprimis NJOF, LLC · Apr 10, 2024
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents…
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
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
Methylergonovine Maleate Tablets
Class IIFailed Dissolution Specifications
Amneal Pharmaceuticals of New York, LLC · Mar 25, 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
Showing 40 of 1,576 Class II recalls (1,895 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.