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Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Esse... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, ... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily,... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deod... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, To... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topica... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deo... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, To... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Ant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, ... Chemical contamination: presence of benzene Class I The Procter & Gamble Company
Nov 23, 2021 Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash ... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Pro... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 19, 2021 Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... Subpotent Drug Class III Lupin Pharmaceuticals Inc.
Nov 19, 2021 AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I American Screening LLC
Nov 19, 2021 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... Product Mix-up Class II Ascent Pharmaceuticals, Inc.
Nov 17, 2021 Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... Temperature Abuse; temperature excursion during shipping Class I Sandoz Inc
Nov 17, 2021 Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... Chemical contamination: Presence of benzene Class I Blistex Inc
Nov 17, 2021 Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 15, 2021 Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... Failed Impurities/Degradation Specifications Class III Aurobindo Pharma USA Inc.
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II SterRx, 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.