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Browse Drug Recalls

378 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 378 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 378 FDA drug recalls in N/A.

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DateProductReasonClassFirm
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.
Dec 23, 2022 CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn ... 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.
Dec 23, 2022 Adventure First Aid 1.5, 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 Class A ANSI 25 Person, First Aid Kit, containing Easy Ca... 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 Marine 150, First Aid Kit, containing Easy Care first aid After Bur... Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... Class I GFA Production Xiamen Co. Ltd.
Nov 10, 2022 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only... Failed Impurities/Degradation Specifications Class II Par Formulations Private Limited
Dec 31, 2021 Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distrib... Complaint received of foreign matter (metal) embedded in tablet. Class II Rubicon Research Private Limited
Aug 12, 2021 Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (... Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the... Class II ANHUI WELCOME FOREIGN TRADE CO.,LTD.
May 11, 2021 DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 11, 2021 ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 11, 2021 ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... Class II DIBAR NUTRICIONAL S DE RL DE CV
May 11, 2021 DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... Class I DIBAR NUTRICIONAL S DE RL DE CV
Mar 17, 2021 Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A... Labeling: Label-mixup Class I Alembic Pharmaceuticals Limited
Dec 8, 2020 Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 1, 2020 Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. ... cGMP deviations: Product made at the same facility where product tested was sub-potent. Class II GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...

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.