Shilpa Medicare Limited has voluntarily recalled approximately 27,923 vials of Pemetrexed Injection (Pemetri RTU™) in the United States due to atypical discoloration. The recall, classified as a Class II by the US FDA, covers 04 batches of the chemotherapy drug. The company stated that no adverse events have been reported and anticipates no material impact on its financial position or operations.
Voluntary Recall of Chemotherapy Drug in US
Shilpa Medicare Limited announced a voluntary recall of 27,923 vials of its Pemetrexed Injection, marketed as Pemetri RTU™, in the United States. The recall was initiated on July 29, 2026, and affects approximately 9,489 vials of the 50 mL strength and 18,434 vials of the 10 mL strength. This action addresses an atypical discoloration of the drug product, described as green to dark green, which deviates from the approved specification of a “clear, colorless to pale yellow to green-yellowish solution.”
FDA Classification and Scope
The recall has been classified by the U.S. Food and Drug Administration (FDA) as a Class II (hospital level) recall. This classification indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company initiated this recall voluntarily, out of an abundance of caution, in consultation with and in accordance with the procedures prescribed by the US FDA. The recall is confined to the specified 04 batches (02 of each strength) and does not impact any other products manufactured or supplied by Shilpa Medicare.
No Adverse Events or Financial Impact Anticipated
Shilpa Medicare has confirmed that no adverse events have been reported to the company in respect of the affected batches. Furthermore, the company does not foresee any material impact of this recall, or the related news item published in The Economic Times on August 17, 2026, on its financial position, operations, or other affairs. This intimation is provided in the interest of transparency to ensure shareholders and investors have accurate information.
Source: BSE
