Browse Drug Recalls

17,625 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,625 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 17,625 FDA drug recalls.

DateProductReasonClassFirm
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 500 mg per vial, Rx only, Mfg. for: Piramal Cri... Lack of Assurance of Sterility Class II Astral SteriTech Private Ltd.
May 15, 2023 Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: ... 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 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 3 grams per vial, Rx only, Manufa... 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 Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Crit... 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 250 mg per vial, Rx only, Mfg. for: Piramal Cr... 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, 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 12, 2023 ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple... Mislabeling: preservative free product labeled as preserved. Class II Empower Clinic Services LLC dba Empower Pharmacy
May 11, 2023 Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... Failed Impurities/Degradation Specifications: Out-of-specification results for total related comp... Class II Hikma Pharmaceuticals USA Inc.
May 11, 2023 Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use O... Sub-potent Drug Class II Revive Rx LLC dba Revive Rx Pharmacy
May 9, 2023 buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... Failed Dissolution Specifications; during stability testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 9, 2023 Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... Subpotent: Low anti-factor IIa Potency. Class II B. Braun Medical Inc
May 9, 2023 HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
May 8, 2023 Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... Class III Amneal Pharmaceuticals of New York, LLC
May 3, 2023 Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL ... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Do... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... CGMP Deviations Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 3, 2023 Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottl... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
May 3, 2023 Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaife... CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class II Denison Pharmaceuticals, LLC
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 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 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 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 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 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 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 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 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 1.25g 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 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
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 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 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 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... Lack of Assurance of Sterility Class II Apollo Care, LLC
May 1, 2023 Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed ... Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an... Class II Glenmark Therapeutics, Inc.
May 1, 2023 LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
May 1, 2023 Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
May 1, 2023 Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II RemedyRepack Inc.
Apr 28, 2023 vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 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 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCI... 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 8:1 High Potassium, 108 mEq K, packaged in 5... 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 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Centr... 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.