Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

Clear
DateProductReasonClassFirm
Jan 19, 2022 Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... Failed stability specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 19, 2022 Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's... Failed stability specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 10, 2022 Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack... Subpotent drug Class III Dr. Reddy's Laboratories, Inc.
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... Mislabeling Class III Teva Pharmaceuticals USA
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package... Mislabeling Class III Teva Pharmaceuticals USA
Jan 4, 2022 QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Dec 29, 2021 Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... Out-of-specification impurity test result observed at 18-month long term stability time point. Class III Lupin Pharmaceuticals Inc.
Dec 22, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... Class III Lupin Pharmaceuticals Inc.
Dec 3, 2021 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neut... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluor... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodi... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 1, 2021 Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... Superpotent; Hydrochlorothiazide Class III Torrent Pharma Inc.
Nov 19, 2021 Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... Subpotent Drug Class III Lupin Pharmaceuticals Inc.
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 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
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 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 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 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
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 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... 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.
Oct 28, 2021 Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... Failed Impurities/Degradation Specifications Class III Teva Pharmaceuticals USA
Oct 25, 2021 Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... Discoloration Class III UNICHEM PHARMACEUTICALS USA INC
Oct 20, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... Class III Lupin Pharmaceuticals Inc.
Oct 18, 2021 Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 13, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation

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.