India Pharma Outlook Team | Monday, 13 October 2025
The US health agency has said that Zydus Lifesciences and Dr. Reddy's Laboratories, two major drug companies, are recalling their goods in the US due to production problems. The US Food and Drug Administration (USFDA) announced in its most recent Enforcement Report that 571 vials of a muscle-relaxing injection are being recalled by an American division of the Hyderabad-based drug major.
Princeton-based Dr Reddy's Laboratories, Inc is recalling the affected lot of Succinylcholine Chloride Injection due to "Out-of-Specification result during the six-month stability testing," the USFDA stated.
Also Read: Dr. Reddy Receives USFDA Notice, Expands Drug Portfolio
On September 26 of this year, the business began the countrywide (US) Class II recall. According to the USFDA, Zydus Lifesciences' US division is recalling more than 1,500 boxes of an antiviral drug that is mostly used to treat chronic hepatitis B infection.
Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to "failed impurity/degradation specifications," it added.
On September 24, the pharmaceutical company started the Class II nationwide recall. According to the USFDA, a Class-II recall is started when there is a low chance of major adverse health outcomes or when using or being exposed to a violative product may cause short-term or medically reversible health effects.
Outside of the US, India has the most USFDA-compliant pharmaceutical facilities.
