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FDA Drug Recalls

1,709 recalls · Class III, newest first

Class III · Low risk Terminated Feb 25, 2022

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals…

Reason Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

Taro Pharmaceuticals U.S.A., Inc. NDC 51672-4048-1 D-0727-2022

Class III · Low risk Terminated Feb 17, 2022

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's…

Reason Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

Dr. Reddy's Laboratories, Inc. D-0640-2022

Class III · Low risk Terminated Feb 14, 2022

Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom…

Reason Subpotent drug

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy D-0569-2022

Class III · Low risk Terminated Jan 19, 2022

Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India…

Reason Failed stability specifications

Dr. Reddy's Laboratories, Inc. NDC 43598-865-60 D-0577-2022

Class III · Low risk Terminated Jan 19, 2022

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…

Reason Failed stability specifications

Dr. Reddy's Laboratories, Inc. NDC 43598-465-62 D-0576-2022

Class III · Low risk Terminated Jan 19, 2022

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046…

Reason Failed stability specifications

Dr. Reddy's Laboratories, Inc. NDC 43598-305-62 D-0575-2022

Class III · Low risk Terminated Jan 10, 2022

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons…

Reason Subpotent drug

Dr. Reddy's Laboratories, Inc. NDC 0363-164-3 D-0388-2022

Class III · Low risk Terminated Jan 7, 2022

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured…

Reason Mislabeling

Teva Pharmaceuticals USA NDC 0093-5455-42 D-0522-2022

Class III · Low risk Terminated Jan 7, 2022

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured…

Reason Mislabeling

Teva Pharmaceuticals USA NDC 0093-5455-28 D-0521-2022

Class III · Low risk Terminated Jan 4, 2022

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 70000-0518-1 D-0386-2022

Class III · Low risk Terminated Jan 4, 2022

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0385-2022

Class III · Low risk Terminated Jan 4, 2022

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 63868-729-10 D-0384-2022

Class III · Low risk Terminated Jan 4, 2022

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 49035-273-20 D-0383-2022

Class III · Low risk Terminated Jan 4, 2022

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0382-2022

Class III · Low risk Terminated Jan 4, 2022

Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 30142-611-14 D-0381-2022

Class III · Low risk Terminated Jan 4, 2022

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. D-0380-2022

Class III · Low risk Terminated Jan 4, 2022

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 0536-1242-07 D-0379-2022

Class III · Low risk Terminated Jan 4, 2022

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a)…

Reason Failed Dissolution Specifications

Dr. Reddy's Laboratories, Inc. NDC 0363-1606-20 D-0378-2022

Class III · Low risk Terminated Dec 29, 2021

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc…

Reason Out-of-specification impurity test result observed at 18-month long term stability time point.

Lupin Pharmaceuticals Inc. NDC 43386-432-01 D-0358-2022

Class III · Low risk Terminated Dec 22, 2021

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA…

Reason Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug…

Lupin Pharmaceuticals Inc. NDC 68180-435-01 D-0326-2022

Class III · Low risk Terminated Dec 3, 2021

CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only…

Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dental Alliance Holdings LLC D-0459-2022

Class III · Low risk Terminated Dec 3, 2021

CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC…

Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dental Alliance Holdings LLC D-0458-2022

Class III · Low risk Terminated Dec 3, 2021

CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC…

Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dental Alliance Holdings LLC D-0457-2022

Class III · Low risk Terminated Dec 3, 2021

CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC…

Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dental Alliance Holdings LLC D-0456-2022

Class III · Low risk Terminated Dec 3, 2021

CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC…

Reason Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.

Dental Alliance Holdings LLC D-0455-2022