FDA Drug Recalls

1,523 recalls · Class III, newest first

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

Class III · Low risk Terminated Dec 3, 2021

CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01…

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

Dental Alliance Holdings LLC D-0454-2022

Class III · Low risk Terminated Dec 3, 2021

CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech…

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

Dental Alliance Holdings LLC D-0453-2022

Class III · Low risk Terminated Dec 3, 2021

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal…

Reason Labeling: Missing Label

Akorn, Inc. NDC 50383-961-34 D-0368-2022

Class III · Low risk Terminated Dec 3, 2021

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY…

Reason Labeling: Missing Label

Akorn, Inc. NDC 50383-965-30 D-0367-2022

Class III · Low risk Terminated Dec 1, 2021

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent…

Reason Superpotent; Hydrochlorothiazide

Torrent Pharma Inc. D-0285-2022

Class III · Low risk Terminated Nov 19, 2021

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets…

Reason Subpotent Drug

Lupin Pharmaceuticals Inc. NDC 68180-904-11 D-0264-2022

Class III · Low risk Terminated Nov 15, 2021

Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279…

Reason Failed Impurities/Degradation Specifications

Aurobindo Pharma USA Inc. NDC 65862-143-05 D-0263-2022

Class III · Low risk Terminated Nov 12, 2021