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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurob... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactur... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Auro... GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethy... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only,... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 31, 2018 Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Au... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Aurobindo Pharma USA Inc.
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... Class III Sun Pharmaceutical Industries, Inc.
Dec 26, 2018 Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC ... Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator Class II Glenmark Pharmaceuticals Inc., USA
Dec 21, 2018 Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufa... Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specificat... Class II LUPIN SOMERSET
Dec 20, 2018 Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 Temozolomide Capsules, 180 mg, packaged in a 14 count bottles, Rx only, Mfd, ... Failed Dissolution Specifications Class III Amerigen Pharmaceuticals Inc.
Dec 20, 2018 LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic ap... GMP Deviations: A silicone particulate was noted in Ozurdex. Class II Allergan, PLC.
Dec 20, 2018 Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 6818... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol ... Failed Stability Specifications: out of specification results for opalescence at 7 month stabilit... Class III Akorn Inc
Dec 20, 2018 Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 6... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained ... Class II Torrent Pharma Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 20, 2018 Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (ND... Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredde... Class I Lupin Pharmaceuticals Inc.
Dec 19, 2018 Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, ... CGMP Deviations Class II Roberts Home Medical LLC
Dec 19, 2018 Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged i... Failed dissolution specifications Class II Teva Pharmaceuticals USA
Dec 18, 2018 CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP ... CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class II LGM Pharma LLC
Dec 17, 2018 Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compoundin... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, ... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Ph... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's He... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, ... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promi... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialis... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide De... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy C... Lack of sterility assurance. Class II Promise Pharmacy, LLC
Dec 17, 2018 Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6... Lack of sterility assurance. Class II Promise Pharmacy, 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.