REGULATORY INTELLIGENCE·Recall
Dr. Reddy's Laboratories Initiates Class II Recall of Omeprazole Due to Foreign Tablet Contamination
Dr. Reddy's Laboratories, Inc. has initiated a Class II recall of 1,476 bottles of Omeprazole Delayed-release Capsules, USP, 20mg, distributed nationwide in the USA. The recall, D-0525-2025, stems from the critical discovery of foreign Divalproex Sodium Extended-Release 250mg tablets within Omeprazole bottles. This event signals significant quality control vulnerabilities at the manufacturing level, demanding immediate attention from procurement and regulatory teams.
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