Browse Drug Recalls
18,041 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,041 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 18,041 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 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 4, 2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... | Presence of foreign substance: Brown/black particles found during stability testing. | Class II | Teva Pharmaceuticals USA, Inc. |
| Nov 1, 2019 | Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufact... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals Inc. |
| Nov 1, 2019 | Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (ND... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals Inc. |
| Nov 1, 2019 | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manuf... | Presence of Foreign substance: identified as a dead ant. | Class III | Lupin Pharmaceuticals 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 |
| Nov 1, 2019 | Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 m... | Presence of Foreign Substance: Black particles were found in the lots during retain sample inspec... | Class II | KVK-Tech, Inc. |
| Oct 31, 2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Po... | Microbial contamination of non-sterile product. | Class II | Fagron, Inc |
| Oct 30, 2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... | Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... | Class II | Avantor Performance Materials Inc |
| 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 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical Inc |
| 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 25, 2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical 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 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 |
| 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 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for:... | Presence of Foreign Substance | Class II | Mylan Pharmaceuticals Inc. |
| 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 | 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 | Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf... | Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato... | Class III | Apotex Inc. |
| 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 22, 2019 | Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 c... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... | Class I | Green Lumber Holdings, 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.