US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-249-10 D-0701-2018
Class II · Moderate risk Terminated

Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-127-10 D-0700-2018
Class II · Moderate risk Terminated

Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile…

Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

Premier Pharmacy Labs Inc NDC 69623-129-10 D-0699-2018
Class III · Low risk Terminated

Ferrous Sulfate 325 MG tablet

Reason Presence of Foreign Tablets/Capsules

Aidarex Pharmaceuticals LLC NDC 33261-0715-00 D-0810-2018
Class III · Low risk Terminated

Cystaran

Reason Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

Leadiant Biosciences, INC NDC 54482-020-01 D-0683-2018
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of specification for adhesive transfer.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-0627-2018
Class III · Low risk Terminated

Triamterene and Hydrochlorothiazide Tablets

Reason Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

Sandoz Incorporated NDC 0781-5067-05 D-0631-2018