Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Dec 21, 2023 Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Fre... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxativ... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 21, 2023 CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Fla... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. Class II Pharma Nobis LLC
Dec 20, 2023 Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. Class II Lupin Pharmaceuticals Inc.
Dec 15, 2023 Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr... Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tac... Class II Dr. Reddy's Laboratories, Inc.
Dec 13, 2023 Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... CGMP Deviations: Stability data does not support expiry date. Class II Private Label Partners, Inc.
Dec 11, 2023 NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. Class II Legacy Pharmaceutical Packaging LLC
Dec 11, 2023 NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 11, 2023 NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Class II Fagron, Inc
Dec 4, 2023 Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distribute... Failed Impurities/Degradation Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Nov 29, 2023 ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Inje... STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag con... Class II STAQ Pharma, Inc.
Nov 22, 2023 B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxin... Presence of Particulate Matter. Class II AnazaoHealth Corporation
Nov 22, 2023 ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... Lack of assurance of sterility. Class II Wells Pharma of Houston LLC
Nov 22, 2023 Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... Failed Dissolution Specifications Class II Lupin Pharmaceuticals Inc.
Nov 22, 2023 Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber... Presence of Particulate Matter. Class II AnazaoHealth Corporation
Nov 14, 2023 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manu... Failed pH Specifications Class II Baxter Healthcare Corporation
Nov 13, 2023 KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Sus... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 13, 2023 KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral ... Failed Impurities/Degradation Specifications Class II KINDER FARMS LLC
Nov 10, 2023 PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 10, 2023 PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-73... Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out o... Class II Golden State Medical Supply Inc.
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, 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.