Dr Reddy’s Laboratories and Zydus Lifesciences are recalling products in the United States due to manufacturing-related quality concerns, according to the US Food and Drug Administration (USFDA).
Dr Reddy’s Recall
- Product: Succinylcholine Chloride Injection (muscle relaxant)
- Quantity: 571 vials
- Reason: Out-of-specification results during six-month stability testing
- Recall Type: Class II, nationwide
- Date Initiated: September 26, 2025
Zydus Lifesciences Recall
- Product: Entecavir tablets (antiviral for chronic hepatitis B)
- Quantity: 912 bottles (0.5 mg) and 600 bottles (1 mg)
- Reason: Failed impurity/degradation specifications
- Recall Type: Class II, nationwide
- Date Initiated: September 24, 2025
Understanding Class II Recalls
A Class II recall is issued when exposure to a product may cause temporary or reversible health effects, or when serious adverse outcomes are unlikely.
India’s Pharma Footprint
India remains the largest hub of USFDA-compliant pharmaceutical plants outside the US, highlighting its significant role in global drug supply chains.
