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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

1,720 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,720 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 1,720 FDA drug recalls, Class III.

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DateProductReasonClassFirm
May 21, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... Failed Impurities/Degradation Specification Class III Fresenius Kabi USA, LLC
May 15, 2013 Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing Class III Novartis Consumer Health
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 15, 2013 Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 15, 2013 Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing. Class III Novartis Consumer Health
May 13, 2013 Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use... Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpu... Class III West-ward Pharmaceutical Corp.
May 7, 2013 Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 11... Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during t... Class III Hill Dermaceuticals, Inc.
Apr 30, 2013 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL)... Subpotent; 24 month stability test station Class III Hi-Tech Pharmacal Co., Inc.
Apr 26, 2013 Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0... Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin p... Class III Teva Pharmaceuticals USA, Inc.
Apr 19, 2013 Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the ... Class III Novartis Consumer Health
Apr 9, 2013 Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufa... Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label Class III Aurobindo Pharma USA Inc
Apr 8, 2013 BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 m... Subpotent; Cetylpyridinum Chloride Class III Hi-Tech Pharmacal Co., Inc.
Apr 5, 2013 Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05)... Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off... Class III Glenmark Generics Inc., USA
Apr 5, 2013 Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90... Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to ... Class III Glenmark Generics Inc., USA
Apr 5, 2013 Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx... Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off ... Class III Glenmark Generics Inc., USA
Apr 4, 2013 Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextrom... Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... Class III Aaron Industries Inc
Mar 27, 2013 Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceu... Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009 Class III Legacy Pharmaceutical Packaging LLC
Mar 22, 2013 buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablet... Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour ... Class III Actavis South Atlantic LLC
Mar 19, 2013 Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for T... CGMP Deviation; cotton coil is missing in some packaged bottles Class III Teva Pharmaceuticals USA, Inc.
Mar 19, 2013 Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By:... Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of ... Class III Dr. Reddy'S Laboratories
Mar 18, 2013 Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care,... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Physicians Total Care, Inc.
Mar 18, 2013 Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets... SubPotent Drug: The firm discovered out of specification results for assay and the extended inves... Class III Boehringer Ingelheim Roxane Inc
Mar 18, 2013 Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-... Subpotent Drug: Product did not conform to the 18-month stability test specification for active ... Class III Reckitt Benckiser Inc
Mar 15, 2013 Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 t... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 15, 2013 Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 15, 2013 Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 15, 2013 Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 ... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 15, 2013 Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 9... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 15, 2013 Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 m... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 14, 2013 Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 e... Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide ... Class III Teva Pharmaceuticals USA, Inc.
Mar 14, 2013 Camrese(TM) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg and E... Failed Impurity/Degradation Specifications; an impurity identified as N-Butyl-Benzene Sulfonamide... Class III Teva Pharmaceuticals USA, Inc.
Mar 12, 2013 Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count... Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica... Class III Teva Pharmaceuticals USA, Inc.
Mar 12, 2013 Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distribut... Failed Impurities/Degradation Specifications: 3 month stability testing. Class III L. Perrigo Co.
Mar 12, 2013 Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, ... Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specifica... Class III Teva Pharmaceuticals USA, Inc.
Mar 11, 2013 Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co.,... Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the... Class III Hi-Tech Pharmacal Co., Inc.
Mar 7, 2013 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, ... Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Mar 7, 2013 Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. t... Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Mar 7, 2013 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydroc... Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Mar 7, 2013 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hy... Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Mar 7, 2013 Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-... Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be ... Class III Novartis Consumer Health
Mar 2, 2013 Voltaren 1% Gel, 100 gm tube, Rx only, Dist By: Physicians Total Care, Tulsa ... Labeling: Incorrect or Missing Lot and/or Expiration Date; This recall is being initiated because... Class III Physicians Total Care, Inc.
Feb 27, 2013 Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 5... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, Inc.
Feb 27, 2013 FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, Inc.
Feb 27, 2013 Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mu... Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in ... Class III Mutual Pharmaceutical Company, Inc.
Feb 26, 2013 Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for... Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identif... Class III Mylan Pharmaceuticals Inc.
Feb 22, 2013 Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Man... Failed Impurities/Degradation Specifications: This product is being recalled due to an out of spe... Class III Lupin Pharmaceuticals 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.