Immunosuppressant Recalled

Dr Reddy’s Laboratories Inc. is recalling 1176 bottles of sirolimus tablets for failing to meet impurities/degradation specifications, according to the May 29, 2024, US Food and Drug Administration (FDA) Enforcement Report. The report provided no additional details on the reason for the recall.

The recall affects 1-mg sirolimus tablets in 100-count bottles (NDC 55111-653-01) from lot H2200493 (Exp. 6/30/25). The product was made in India and distributed throughout the United States by Dr Reddy's Laboratories Inc., Princeton, New Jersey.

Dr Reddy’s Laboratories voluntarily initiated the recall on May 1, 2024. The FDA designated it Class III on May 21, 2024, suggesting use of the recalled tablets is not likely to cause harm.

Sirolimus is a prescription immunosuppressive drug with indications for prophylaxis of organ rejection in patients receiving renal transplants and for the treatment of patients with lymphangioleiomyomatosis.