Browse Drug Recalls

399 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 399 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 399 FDA drug recalls in N/A.

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DateProductReasonClassFirm
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Ma... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xe... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manu... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xe... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critica... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cr... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manuf... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cri... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfg. f... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. f... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xel... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Phar... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufac... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civi... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmac... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Criti... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 1g per vial, Rx only, Manufactured for: Xellia ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Cr... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg.... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Man... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critica... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xell... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg.... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only,... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cr... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for:... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd fo... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, M... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd ... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, M... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
Apr 19, 2023 Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. Class II Sun Pharmaceutical Industries Ltd.
Feb 24, 2023 Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83... Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because th... Class II Global Pharma Healthcare Private Limited
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Dec 23, 2022 Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hyd... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Dec 23, 2022 Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.

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.