Glenmark, Sun Pharma recall products in US over manufacturing issues
What's the story
Glenmark Pharmaceuticals, Sun Pharmaceutical Industries, and Zydus Pharmaceuticals (USA) Inc. have started recalling products in the US over manufacturing issues.
The US Food and Drug Administration (USFDA) flagged the issues in its latest Enforcement Report.
Glenmark is recalling more than 25 products from the American market for deviations from Current Good Manufacturing Practice (CGMP).
Recall details
Glenmark's Class II recall
Glenmark's US subsidiary, Glenmark Pharmaceuticals Inc, is recalling certain lots of medicines, including Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets.
Other recalled products include Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets, and Rufinamide Tablets.
The company launched a Class II recall on March 13 this year.
A Class-II recall is issued when exposure to a non-compliant product could lead to temporary or medically reversible health effects, or serious adverse health outcomes are unlikely, according to the USFDA.
Contamination issue
Sun Pharma's recall due to cross-contamination
A US-based subsidiary of Sun Pharma is recalling some 13,700 bottles of Gabapentin capsules. The capsules are used for treating and preventing seizures in patients suffering from epilepsy.
New Jersey-based Sun Pharmaceutical Industries Inc. initiated the recall on March 4, 2025, due to cross-contamination, the USFDA reported.
It is a Class III recall, meaning the product is not likely to cause any adverse health effects.
Zydus recall
Zydus's recall for chlorproMAZINE Hydrochloride Tablets
Zydus Pharmaceuticals (USA) Inc is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets, USP 10mg. The tablets are used to treat mental health conditions like schizophrenia and bipolar disorder.
The company initiated the Class II recall on April 3, 2025, due to CGMP deviations according to the USFDA report.
The issue was identified as "presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit."