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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
Dec 17, 2019 Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 13, 2019 RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Granules India Limited
Dec 11, 2019 Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... Class II RemedyRepack Inc.
Dec 2, 2019 Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03),... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Preferred Pharmaceuticals, Inc
Nov 22, 2019 Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 22, 2019 Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II Amneal Pharmaceuticals, Inc.
Nov 20, 2019 Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II American Health Packaging
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in... cGMP violations Class II Wisconsin Pharmacal Company, LLC
Nov 13, 2019 Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per c... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. Class II Precision Dose Inc.
Nov 8, 2019 Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively ... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X;... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India excl... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exc... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in Ind... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Cal... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 8, 2019 Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 2... CGMP Deviations: products were not manufactured under current good manufacturing practices. Class II Washington Homeopathic Products, Inc.
Nov 6, 2019 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed b... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-0... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Golden State Medical Supply Inc.
Nov 6, 2019 DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-0... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Golden State Medical Supply Inc.
Nov 1, 2019 Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... CGMP Deviations: Presence of NDMA impurity detected in product. Class II American Health Packaging
Oct 28, 2019 Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Di... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Lannett Company, Inc.
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured b... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 25, 2019 Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Novitium Pharma LLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 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, 50 tablets per... 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, 30 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, 95 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, 24 tablets per... 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, 160 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC

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.