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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

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Dec 8, 2022 Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/... Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... Class II McGuff Compounding Pharmacy Services, Inc.
Dec 7, 2022 Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Lupin Pharmaceuticals Inc.
Dec 7, 2022 Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. Class II Lupin Pharmaceuticals Inc.
Dec 5, 2022 Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315... Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. Class II RemedyRepack Inc.
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable ... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022 TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl... Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. Class II GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 1, 2022 Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185... Presence of foreign substance Class II SUN PHARMACEUTICAL INDUSTRIES INC
Nov 29, 2022 FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Fre... Underfilled units. Class II OurPharma LLC
Nov 25, 2022 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... Lack of sterility assurance: Bags have the potential to leak. Class II B. Braun Medical, Inc.
Nov 23, 2022 Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed b... Subpotent Drug Class II Heritage Pharmaceuticals Inc
Nov 22, 2022 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 22, 2022 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... Class II Fresenius Medical Care Holdings, Inc.
Nov 22, 2022 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epineph... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 22, 2022 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 16, 2022 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (... Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is ... Class II Noven Pharmaceuticals Inc
Nov 10, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Nov 10, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Nov 10, 2022 Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only... Failed Impurities/Degradation Specifications Class II Par Formulations Private Limited
Nov 9, 2022 Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, I... Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. Class II ImprimisRx NJ
Nov 9, 2022 Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... CGMP deviations Class II DISCOVERY PHARMA LLC
Nov 9, 2022 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ... Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which ... Class II ICU Medical Inc
Nov 5, 2022 Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured u... Class II Adam's Polishes LLC
Nov 2, 2022 Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... cGMP deviation: discontinue of stability support for product. Class II Direct Rx
Oct 21, 2022 Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma... Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. Class II Viatris Inc
Oct 18, 2022 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx... Presence of Foreign Substance Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... CGMP Deviations: Class II Akorn, 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.