Glenmark, Sun Pharma, Zydus Recall Multiple Products in the US Over Quality Concerns

In a recent enforcement report published by the US Food and Drug Administration (USFDA), three major Indian drugmakers Glenmark, Sun Pharma, and Zydus have voluntarily initiated recalls of various medications in the US due to concerns over production quality and regulatory non-compliance.

Glenmark Recalls Over 25 Products

Glenmark Pharmaceuticals is recalling more than 25 pharmaceutical products from the US market. The decision stems from deviations from the USFDA’s Current Good Manufacturing Practice (CGMP) norms.

The recall involves medications produced by Glenmark Pharmaceuticals Inc., based in New Jersey. Among the affected products are widely prescribed medications.

The USFDA has categorised this as a Class II recall, which applies to products that may cause temporary or medically reversible adverse health consequences, with a low likelihood of serious health effects. The recall was initiated on March 13, 2025.

Sun Pharma Recalls Gabapentin Capsules

Sun Pharmaceutical Industries Inc., another New Jersey-based entity and subsidiary of India’s Sun Pharma, is recalling 13,700 bottles of Gabapentin capsules.

Gabapentin is used to manage and prevent seizures in patients with epilepsy. According to the USFDA, the recall classified as Class III was triggered due to concerns about possible cross-contamination during manufacturing. The recall began on March 4, 2025.

Class III recalls apply to products that are unlikely to cause adverse health consequences but still fail to meet manufacturing standards.

Zydus Recalls Antipsychotic Medication

Zydus Pharmaceuticals (USA) Inc. has recalled 3,144 bottles of Chlorpromazine Hydrochloride Tablets (USP 10 mg) — a medication commonly prescribed for psychiatric disorders like schizophrenia and bipolar disorder.

The recall was initiated due to CGMP deviations. Specifically, the batch contained levels of N-Nitroso-Desmethyl Chlorpromazine impurity exceeding the interim safety limits recommended by regulatory authorities. This is categorised as a Class II recall and began on April 3, 2025.

Conclusion

The recent recalls by Glenmark, Sun Pharma, and Zydus underscore the importance of strict adherence to global manufacturing and quality standards, especially when operating in regulated markets like the US.

While these recalls may raise short-term concerns, they also demonstrate the companies’ commitment to regulatory compliance and patient safety.

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