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Browse Drug Recalls

3,378 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,378 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 3,378 FDA drug recalls.

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DateProductReasonClassFirm
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [ND... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 22, 2019 Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Compa... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 22, 2019 Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Sanofi-Aventis U.S. LLC
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE 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 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 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, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OT... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-3... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)9... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, 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 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 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 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 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 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 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.

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.