Drug firm Shilpa Medicare Ltd on Tuesday (August 18) announced a voluntary recall of 27,923 vials of Pemetrexed Injection in the United States due to atypical discolouration. According to a stock exchange filing, the recall was initiated on July 29, 2026, at the retail and hospital level and covers four batches - two of each strength. The affected products comprise 9,489 50 mL vials and 18,434 10 mL vials of Pemetrexed Injection 100 mg/10 mL and 500 mg/50 mL (Pemetri RTU). The recall follows market complaints about the colour of the injectable drug, with the reported green to dark-green appearance prompting corrective action.
The affected drug showed green to dark green discolouration, which is not consistent with the approved specification for appearance, defined as a clear, colourless to pale yellow to green-yellowish solution. As reported by CNBC TV18, the US Food and Drug Administration (US FDA) has classified the recall as a Class II hospital-level recall. The company emphasized that the recall was initiated voluntarily as a precaution, in consultation with and in accordance with the procedure prescribed by the US FDA. The FDA classification indicates that exposure to a violative product could cause temporary or medically reversible health consequences, although the probability of serious harm is considered remote.
Shilpa Medicare stated it does not foresee any material impact from the recall on its financial position, operations or other affairs. According to the company's filing, the recall is confined to the four affected batches and does not affect any other product of the company, its manufacturing arrangements or the supply of its products to customers. No adverse event has been reported to the company in respect of the affected batches.
In June this year, Shilpa Medicare announced that its wholly-owned subsidiary, Shilpa Biologicals Private Ltd (SBPL), had entered a co-development and supply agreement with Finland-based Orion Corporation for an intravenous (IV) nivolumab biosimilar for the European market. As reported by CNBC TV18, Shilpa Biologicals will co-develop, manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka, while Orion will have exclusive rights to register, market, distribute and sell the product across Europe. The affected product, Pemetrexed Injection, is a chemotherapy medicine used in the treatment of certain cancers, with Shilpa Medicare's portfolio including Pemetrexed products for the US and other regulated markets.
Shares of Shilpa Medicare Ltd ended at ₹810.10, up by ₹1.40, or 0.17%, on the BSE. The company noted that the partnership aims to expand patient access to a high-quality biosimilar following the loss of exclusivity of the originator nivolumab in Europe. According to CNBC TV18, Shilpa Biologicals will be eligible to receive development and regulatory milestone payments, in addition to supply revenue over the duration of the partnership.
