US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Biest Td 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0193-2016
Class II · Moderate risk Terminated

Biest Td 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0192-2016
Class II · Moderate risk Terminated

Biest Td 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0191-2016
Class II · Moderate risk Terminated

Biest Td 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0190-2016
Class II · Moderate risk Terminated

Biest Td 67/33

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0189-2016
Class II · Moderate risk Terminated

Biest Td 50/50

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0188-2016
Class II · Moderate risk Terminated

Biest Td 50/50

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0187-2016
Class II · Moderate risk Terminated

Biest Cp 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0186-2016
Class II · Moderate risk Terminated

Biest Cp 80/20

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0185-2016
Class II · Moderate risk Terminated

Biest Cp 76/24: Dhea

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0184-2016
Class II · Moderate risk Terminated

Biest 80/20 : Progest : Dhea : Testost

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0183-2016
Class II · Moderate risk Terminated

Biest 66/34: Testosterone : Progesterone in Olive Oil

Reason Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

the Compounder D-0182-2016
Class II · Moderate risk Terminated

Fomepizole Injection

Reason Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.

Navinta LLC NDC 0781-3182-73 D-0431-2015
Class II · Moderate risk Terminated

Dicopanol

Reason Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

Fusion Pharmaceuticals, LLC D-0410-2015
Class II · Moderate risk Terminated

5% DEXTROSE Injection

Reason Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Hospira Inc. NDC 0409-7100-02 D-0417-2015
Class II · Moderate risk Terminated

Haloperidol Oral Solution

Reason Defective Container: Confirmed customer complaints of leaking bottles.

Safecor Health, LLC NDC 54838-0501-40 D-0661-2016
Class II · Moderate risk Terminated

Fluticasone Propionate Nasal Spray

Reason Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

Akorn, Inc. NDC 50383-700-16 D-0405-2015
Class II · Moderate risk Terminated

Minivelle

Reason Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

Noven Pharmaceuticals, Inc. NDC 68968-6650-8 D-0485-2015
Class II · Moderate risk Terminated

RIFAMPIN for Injection

Reason Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Heritage Pharmaceuticals, Inc. NDC 23155-340-31 D-0416-2015
Class II · Moderate risk Terminated

Colistimethate for Injection USP

Reason Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

Heritage Pharmaceuticals, Inc. NDC 23155-193-31 D-0415-2015
Class II · Moderate risk Terminated

Droperidol injection

Reason Presence of particulate.

SCA Pharmaceuticals D-0965-2015
Class II · Moderate risk Terminated

Promethazine Dm Syrup

Reason Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

Qualitest Pharmaceuticals D-0411-2015
Class II · Moderate risk Terminated

Atracurium Besylate Injection

Reason Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Sagent Pharmaceuticals Inc NDC 25021-672-10 D-0399-2015
Class II · Moderate risk Terminated

Atracurium Besylate Injection

Reason Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Sagent Pharmaceuticals Inc NDC 25021-659-05 D-0398-2015