Dr.Reddy’s recall Sirolimus tablets for impurities

Dr.Reddy’s (DRL) is recalling 1176 bottles of Sirolimus 1mg tablets (NDC 55111-653-01) in US for failed impurities in degradation specification. The recall was initiated on 1 May 2024. Sirolimus (also known as Rapamycin) is an immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving renal transplants.

DRL had recalled Sirolimus tablets earlier as well.  Sirolimus tablets were recalled once in 2016 and again in 2021 for failed impurities; (NDC 55111-653-01, recalled by DRL in 2016) and (NDC 68084-915-25, recalled by American Health Packaging). The Sirolimus tablets recall in 2016 was due to out of specification result for impurity secorapamycin. Typical limits for secorapamycin is 1.5% and degradation impurities 2.0% in Sirolimus tablets (reference USP draft monograph for Sirolimus Tablets in USP Pharmacopeia Forum).

USFDA Enforcement report for DRL Sirolimus tablets (2024)