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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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DateProductReasonClassFirm
Oct 1, 2019 Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D... Subpotent Drug Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ... Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. Class III Sato Pharmaceutical Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 1... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distri... Subpotent Drug Class III Sato Pharmaceutical Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Man... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manu... Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... Class II Taro Pharmaceuticals U.S.A., Inc.
Sep 27, 2019 Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,... Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1... Class III Arbor Pharmaceuticals Inc.
Sep 26, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed ... Class II Alkermes, Inc.
Sep 26, 2019 Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic P... Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol... Class II Epic Pharma, LLC
Sep 24, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by... Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle Class III Amneal Pharmaceuticals, Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 23, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles... Class III AuroMedics Pharma LLC
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manu... Superpotent Class II Macleods Pharma Usa Inc
Sep 23, 2019 Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl o... Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 Class II Morton Grove Pharmaceuticals, Inc.
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 20, 2019 Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ... Lack of Assurance of Sterility: Out of specification results for container closure test which can... Class II Akorn, Inc.
Sep 19, 2019 Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 19, 2019 Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate... Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for wei... Class II Aurobindo Pharma USA Inc.
Sep 19, 2019 Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II Torrent Pharma Inc.
Sep 18, 2019 Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... Lack of sterility assurance. Class II Avella of Deer Valley, Inc. Store 38
Sep 18, 2019 Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... Microbial Contamination of Non-Sterile Product. Class II GCP Laboratories Inc
Sep 17, 2019 Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac... cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub... Class II Akorn, Inc.
Sep 16, 2019 Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2... Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. Class I FITOTERAPIA USA, INC
Sep 13, 2019 Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, pac... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class II GUERBET LLC
Sep 13, 2019 Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille... Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... Class III GUERBET LLC
Sep 12, 2019 LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 m... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL)... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.03... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill... Lack of Assurance of Sterility Class II KRS Global Biotechnology, 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.