Sun Pharma, Zydus and 3 others recall products in US

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-09-29 06:56 GMT | Update On 2025-09-29 06:56 GMT

New Delhi: Sun Pharma, Zydus, Glenmark, Granules India, and Unichem are recalling products in the United States due to various manufacturing concerns, according to the latest Enforcement Report of the US Food and Drug Administration (USFDA).

The recalls of affected lots are being made voluntarily by the companies in the American market, the US health regulator said.

A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said.

As per PTI, New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17.

As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

Hyderabad-based Granules India is recalling over 49,000 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, extended-release capsules in multiple strengths due to "failed impurities/degradation specifications", USFDA said.

The US-based arm of the company issued the Class III recall on August 28.

As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".

The US health regulator stated that a US-based subsidiary of the drug major Sun Pharma is recalling 1,870 kits of renal imaging agent.

The Class II recall announced on September 3 is due to the failed dissolution specifications, it added.

Zydus Pharmaceuticals (USA) Inc, a unit of Ahmedabad-based drugmaker, is recalling 8,784 bottles of antiviral drug Entecavir tablets, due to "failed impurity/ degradation specifications," USFDA stated.

The company initiated the Class II recall on September 4.

Another drug firm Unichem Pharmaceuticals USA Inc is recalling 230 90-count bottles for label mix-up, USFDA said.

The East Brunswick-based firm issued the Class I recall on August 27, it added.

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Sun Pharma, Zydus and 3 others recall products in US

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