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Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
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.
May 2, 2023 VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Ap... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only,... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Ap... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, A... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 2, 2023 FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL ... Lack of Assurance of Sterility Class II Apollo Care, LLC
Apr 28, 2023 PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 m... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Centra... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Ce... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low ... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx o... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIU... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Cent... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Se... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, pack... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, Inc.
Apr 28, 2023 Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K,... Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... Class II Central Admixture Pharmacy Services, 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.