Browse Drug Recalls

2,151 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,151 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 2,151 FDA drug recalls.

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DateProductReasonClassFirm
Aug 23, 2013 Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solu... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II JCB Labs LLC
Aug 23, 2013 Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-80... Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 23, 2013 NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183 Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (fr... Class II Medaus, Inc.
Aug 9, 2013 CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% ... Non Sterility: Microbial contamination Class I Specialty Compounding, LLC
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per b... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx on... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx onl... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 table... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 ... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle, Rx only Physicia... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bo... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 8, 2013 Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-N... Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottle... Class II Novartis Pharmaceuticals Corp.
Aug 6, 2013 REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple... Microbial Contamination of a Non-Sterile Products: Product was found to be contaminated with the ... Class II Showline Automotive Products, Inc. dba US Soaps...
Aug 2, 2013 Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum S... Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of... Class II Dr. Reddy's Laboratories, Inc.
Jul 18, 2013 ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, ... Microbial Contamination of Non-Sterile Products: This product is being recalled because a stabili... Class III Vi-Jon, Inc.
Jun 20, 2013 AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infu... Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bact... Class II Gilead Sciences, Inc.
Jun 19, 2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... Class II Astellas Pharma US Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
Jun 11, 2013 Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Gra... Presence of Foreign Substance: raw material recalled due to stainless steel and other contamination. Class II Church & Dwight Inc
May 16, 2013 West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bott... Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets containe... Class II West-Ward Pharmaceutical Corp.
May 8, 2013 Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopano... Class II Fusion Pharmaceuticals, LLC
Apr 18, 2013 Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for S... Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 ... Class II Sandoz Incorporated
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
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count ... Chemical contamination: emission of strong odor after package was opened.. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-coun... Chemical contamination: emission of strong odor after package was opened Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count ... Chemical contamination: emission of strong odor after package was opened.. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened.. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count ... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer Inc.
Mar 28, 2013 Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count... Chemical contamination: emission of strong odor after package was opened. Class II Pfizer 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 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.
Feb 15, 2013 Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) ... Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin ... Class II Dr Reddys Laboratories Tennessee LLC

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.