Browse Drug Recalls

17,539 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,539 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 17,539 FDA drug recalls.

DateProductReasonClassFirm
Apr 24, 2024 Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC... Discoloration: Dotted and yellow spots on tablets Class II Aurobindo Pharma USA Inc.
Apr 24, 2024 Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vial... Presence of Foreign Substance: This oil based product may contain trace amounts of water for inje... Class II SOMERSET THERAPEUTICS LLC
Apr 24, 2024 Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC ... Discoloration: Dotted and yellow spots on tablets Class II Aurobindo Pharma USA Inc.
Apr 24, 2024 Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. Class II Lupin Pharmaceuticals Inc.
Apr 23, 2024 minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 23, 2024 Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, N... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 23, 2024 minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
Apr 23, 2024 EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... Lack of Assurance of Sterility: Complaints of syringe breakage Class II Regeneron Pharmaceuticals Inc
Apr 22, 2024 Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... Marketed Without An Approved NDA/ANDA Class I Stop Clopez Corp
Apr 22, 2024 Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... Failed Release Testing: Out of specification for particulate matter test. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
Apr 19, 2024 GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx ... Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... Class II Nomax Inc
Apr 19, 2024 FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein... Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... Class II Nomax Inc
Apr 19, 2024 Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: S... Out of specification for assay Class II SUN PHARMACEUTICAL INDUSTRIES INC
Apr 19, 2024 GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx ... Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... Class II Nomax Inc
Apr 19, 2024 FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips pe... Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in ... Class II Nomax Inc
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor ... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menth... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octy... Out of Specification for active ingredient Class II ARG Laboratories, Inc.
Apr 17, 2024 NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched ... Out of Specification for active ingredient. Violative grade of propylene glycol used during the m... Class II ARG Laboratories, Inc.
Apr 17, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... Failed Dissolution Specifications Class II Glenmark Pharmaceuticals Inc., USA
Apr 12, 2024 Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar... cGMP Deviations Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Apr 10, 2024 Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... Subpotent Drug Class II Imprimis NJOF, LLC
Apr 10, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... Out of specification for assay Class III Imprimis NJOF, LLC
Apr 9, 2024 Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 9, 2024 Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... Cross Contamination with Other Products Class III Second Tokushima Factory, Otsuka Pharmaceutical...
Apr 8, 2024 Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 8, 2024 Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Mar 29, 2024 Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents:... CGMP Deviations Class II HONEYWELL INC
Mar 28, 2024 Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx O... Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Class II Teva Pharmaceuticals USA, Inc
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Mar 27, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... CGMP Deviations Class II NATCO Pharma Limited
Mar 27, 2024 NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottl... Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month... Class III Esperion
Mar 26, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution... Class II Glenmark Pharmaceuticals Inc., USA
Mar 26, 2024 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3... Short fill: Complaints received of less fill volume in respule and few drops of liquid observed i... Class II Cipla USA, Inc.
Mar 25, 2024 Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distr... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Mar 25, 2024 Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufa... Failed Impurities/Degradation Specifications Class III Novitium Pharma LLC
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.