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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
Nov 11, 2019 Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, p... Presence of Foreign Substance: Foreign material found inside the vial. Class II AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
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 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 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 UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) ... Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... Class I Med Man Distribution, 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 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 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 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 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 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 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 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 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 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 Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Te... Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... Class I Med Man Distribution, 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 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 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 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 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 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 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 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 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 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 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.
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 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 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 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.
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 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 300 mg 100 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 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 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 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 150 mg 500 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, 60 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, 90 t... 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, 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, Ranitidine tablets, USP 150 mg, 95 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, 150 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

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.