Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Apr 12, 2022 Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... Subpotent Drug: Out of specification for assay. Class III American Health Packaging
Apr 5, 2022 Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... Subpotent Drug: Out of Specification results for Assay Class III Aurobindo Pharma USA Inc.
Apr 1, 2022 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... Class III The Ritedose Corporation
Apr 1, 2022 Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 1, 2022 Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Mar 29, 2022 Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ... Incorrect/Undeclared Excipient: Product contains alcohol Class III AptaPharma Inc.
Mar 18, 2022 NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... Class III Advanced Accelerator Applications USA, Inc.
Mar 16, 2022 Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... Failed Impurities/Degradation Specifications: Out of Specification results for related substance. Class III Dr. Reddy's Laboratories, Inc.
Mar 10, 2022 Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... FAILED CONTENT UNIFORMITY SPECIFICATIONS Class III Macleods Pharma Usa Inc
Mar 8, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 17, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... Class III Dr. Reddy's Laboratories, Inc.
Feb 14, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... Subpotent drug Class III BayCare Integrated Service Center, LLC /dba Bay...
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, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ... 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, package... Mislabeling Class III Teva Pharmaceuticals USA
Jan 7, 2022 Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag... Mislabeling Class III Teva Pharmaceuticals USA
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 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.
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 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 QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... 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 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 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 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 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 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 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 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 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 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 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.

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.