Dr Reddy’s and Zydus Lifesciences Initiate US Recalls Over Manufacturing Issues

Dr Reddy’s and Zydus Lifesciences Initiate US Recalls Over Manufacturing Issues

By, Admin 13 October 2025

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.

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