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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.

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DateProductReasonClassFirm
Mar 20, 2026 Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by... CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Class II Leading Pharma, LLC
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, C... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Me... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, ... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Va... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Men... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Straw... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, S... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Ho... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Su... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flav... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar F... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, F... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, ... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP,... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection US... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 19, 2026 Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manu... Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f... Class II Amneal Pharmaceuticals, LLC
Mar 17, 2026 Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL S... Labelling: Illegible label Class II Nephron SC, LLC
Mar 17, 2026 Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx ... Failed Dissolution Specifications Class II Viatris, Inc.
Mar 17, 2026 CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... Lack of Assurance of Sterility Class II Chiesi USA, Inc.
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 17, 2026 Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... Class II Teva Pharmaceuticals USA, Inc
Mar 16, 2026 Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Cipla USA, Inc.
Mar 16, 2026 Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Cipla USA, Inc.
Mar 16, 2026 Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manu... CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Class II Cipla USA, Inc.
Mar 16, 2026 Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60... Failed tablet specifications. Class II Amerisource Health Services LLC
Mar 13, 2026 Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, R... Presence of particulate matter: identified as Buprenorphine free base Class II ENDO USA, Inc.
Mar 13, 2026 Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1... Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... Class II Cipla USA, Inc.
Mar 13, 2026 Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Singl... Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for ... Class II Cipla USA, Inc.
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL i... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 m... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL i... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 1... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC

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.