Immunosuppressant Recalled

Dr. Reddy’s Laboratories Inc. is recalling 8280 bottles of 1-mg tacrolimus capsules. According to the January 17, 2024, US Food and Drug Administration (FDA) Enforcement Report, a 0.5-mg tacrolimus capsule was discovered in a bottle.

The recall affects tacrolimus capsules, 1 mg, in 100-count bottles (NDC 55111-526-01), from lot C2307275 (Exp. 1/26). The capsules were manufactured by Dr. Reddy’s Laboratories Limited, Bachupally, India, and were distributed throughout the United States.

Dr. Reddy’s Laboratories voluntarily initiated the recall December 15, 2023. The FDA designated the recall Class II on January 5, 2024, signaling use of the recalled capsules could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. Tacrolimus is a prescription immunosuppressive agent used for the prophylaxis of organ rejection in adults receiving kidney, liver, heart, or lung transplant.