Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

Clear
DateProductReasonClassFirm
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Apr 30, 2024 Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl... Failed Impurities/Degradation Specifications Class II Viatris Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 29, 2024 Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc
Apr 26, 2024 traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri... Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t... Class II Rubicon Research Private Limited
Apr 25, 2024 Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co... Class II FDC Limited
Apr 25, 2024 MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 m... Presence of Particulate Matter: Potential for black particulates in the drug product. Class II Sagent Pharmaceuticals
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 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 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 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 Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... Presence of Foreign Substance; Broken metal piece found embedded in tablet. Class II Coast Quality Pharmacy, LLC dba Anazao Health
Apr 24, 2024 Cefdinir for Oral Suspension USP 125 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 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 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 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, 135mg 30-count... CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product ... Class II EPI Health, LLC
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 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 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 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 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Do... Failed Dissolution Specifications Class II Glenmark Pharmaceuticals Inc., USA
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 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 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 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 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
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 27, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treat... CGMP Deviations Class II NATCO Pharma Limited
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 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 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 22, 2024 fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... Lack of Assurance of Sterility: leaking bags Class II IntegraDose Compounding Services LLC
Mar 22, 2024 Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... Lack of assurance of sterility: bags have the potential to leak.. Class II B. Braun Medical Inc
Mar 21, 2024 VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... cGMP Diviations Class II Apothecus Pharmaceutical Corp.
Mar 21, 2024 Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... Subpotent Drug Class II Lupin Pharmaceuticals Inc.
Mar 12, 2024 Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... The filter included in the carton has an expiration date that has expired prior to the expiration... Class II Hikma Pharmaceuticals USA Inc.
Mar 12, 2024 Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... CGMP Deviations Class II Eli Lilly & Company
Mar 7, 2024 Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... Failed Dissolution Specifications Class II Teva Pharmaceuticals USA, Inc

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.