Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in
