Browse Drug Recalls

2,193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,193 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 2,193 FDA drug recalls in NJ.

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DateProductReasonClassFirm
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks ... Class II West-Ward Pharmaceutical Corp.
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 13, 2013 Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufa... Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who disc... Class I Zydus Pharmaceuticals USA Inc
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 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 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 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 2, 2013 Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202... Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three ac... Class II Cetylite Industries, Inc.
Mar 22, 2013 Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx onl... Failed Tablet/Capsule Specifications: Broken tablets Class II Actavis 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 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 18, 2013 Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), R... Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration... Class II West-ward Pharmaceutical Corp.
Mar 18, 2013 Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, ... Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months. Class II West-ward Pharmaceutical Corp.
Mar 14, 2013 All Compounded Products, packaged in plastic infusion bags, devices, syringes... Lack of Assurance of Sterility; potential for mold contamination Class II Med Prep Consulting, Inc.
Mar 14, 2013 Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infu... Non-Sterility; mold contamination Class I Med Prep Consulting, Inc.
Mar 7, 2013 Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd... Subpotent drug: low fill volume in some of the capsules Class II Sanofi US
Mar 5, 2013 Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx o... Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/o... Class II Zydus Pharmaceuticals USA Inc
Feb 13, 2013 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceed... Class III Actavis Elizabeth LLC
Feb 13, 2013 Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per... Chemical Contamination: The recall has been initiated based on multiple complaints received from ... Class III Glenmark Generics Inc., USA
Feb 6, 2013 Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured fo... Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg... Class II West-ward Pharmaceutical Corp.
Feb 1, 2013 TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... Class III Ferring Pharmaceuticals Inc
Jan 7, 2013 Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, U... Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets. Class II West-ward Pharmaceutical Corp.
Jan 7, 2013 Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactu... Subpotent Drug Class III West-ward Pharmaceutical Corp.
Jan 4, 2013 buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bot... Failed Dissolution Specifications; 8-hours for the 18-month stability testing point. Class III Actavis Pharmaceuticals
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tub... Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... Class III Ranbaxy Inc.
Dec 27, 2012 Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only... Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which ... Class III Ranbaxy Inc.
Dec 22, 2012 Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules ... Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenaf... Class I D& S Herbals, LLC
Dec 18, 2012 Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 36... Failed Dissolution Specification: Out of a specification result occurred during the 3-month stabi... Class II Watson Pharmaceuticals
Dec 7, 2012 Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottl... Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifen... Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from t... Class III Bayer Healthcare, LLC
Dec 7, 2012 Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bo... Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tab... Class II West-ward Pharmaceutical Corp.
Dec 7, 2012 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N... Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant ... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the t... Class II West-ward Pharmaceutical Corp.
Dec 5, 2012 PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (... Presence of Foreign Substance: A complaint was received for black specks identified as stainless ... Class II West-ward Pharmaceutical Corp.
Dec 4, 2012 Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-... Failed Dissolution Specifications; 36 month stability timepoint Class II West-ward Pharmaceutical Corp.
Dec 4, 2012 Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC,... Superpotent (Single Ingredient Drug): salicylic acid Class III Johnson & Johnson
Nov 30, 2012 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-c... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 617... Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored. Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, M... Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Regist... Class III West-ward Pharmaceutical Corp.
Nov 21, 2012 Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector S... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 21, 2012 Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 9, 2012 Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Nov 9, 2012 Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Nov 9, 2012 Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Oct 15, 2012 AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g)... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals

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.