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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... CGMP Deviations Class II SUN PHARMACEUTICAL INDUSTRIES INC
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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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 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 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.
Apr 28, 2023 EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx... 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 low potassium, 24 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 diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial A... 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 vancomycin added to 0.9% sodium chloride, 1.25 g/250 mL* (5 mg/mL), 250 mL pe... 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 vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 10... 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) 3%/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, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODI... 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 EPINEPHrine added to dextrose 5%, 4 mg/250 mL* (16 mcg/mL), 250 mL per bag, R... 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 dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx... 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 4:1 Plasma-Lyte/Tromethamine, low potassiu... 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 phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 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 vancomycin added to 0.9% sodium chloride, 1.5 g/250 mL* (6 mg/mL), 250 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 Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, p... 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) 3.5%/Dextrose 10%, package... 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/low dextrose, 100 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.
Apr 28, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40... 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 High Potassium, 30 mEq K, packaged in 41... 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) 6%/Dextrose 10% with low c... 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) 2.5%/Dextrose 10% with CAL... 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 4:1 low potassium/low tromethamine, 36 mEq... 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) 2%/Dextrose 10% with low c... 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 Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central... 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) 3.5%/Dextrose 10% with CAL... 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 MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixtur... 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 NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 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.

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.