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Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Mar 20, 2013 Latanoprost 0.025% eye drop, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 B... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Hydroxyprogesterone 250 mg/ml, Clinical Specialties Compounding Pharmacy, 318... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Pap 300 mg-phent 10 mg-prost 100 mcg, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Acetylcysteine 20 % solution, 100 ml bottle, Clinical Specialties Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-estradiol cyp 7 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 10 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 100 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Roa... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 200 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Roa... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Laser ophthalmic drops, 12 mL bottle, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cataract drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, A... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Ba... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-Estadiol valerate 15 mg/mL, Clinical Specialties Compounding P... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 75 mg-estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 1000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 500 units/ml, 10 mL syringe, Clinical Specialties Compounding Pharmacy, 3... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 25 mg-Estradiol cyp 5 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy,... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharma... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
Mar 20, 2013 Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Clinical Specialties Compounding Pharmacy
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 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 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 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 Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk ... Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon rec... Class I Apotex Corp.
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 16, 2013 "Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simeth... Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count ... Class II Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
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 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 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 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 Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bo... Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class II Palmer Natural Products
Mar 11, 2013 Brain Defogger, Piracetam 390mg Choline 104mg capsules, 100 count bottle, OTC... Marketed Without an Approved NDA/ANDA: The products are unapproved drugs Class II Palmer Natural Products

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.