Shilpa Medicare recalls 27,923 Pemetrexed vials in US over discolouration
Synopsis
Shilpa Medicare has pulled 27,923 vials of its cancer-treatment drug Pemetrexed from US retail and hospital shelves after batches turned green — a colour the drug is not supposed to be. The US FDA has classified it as a Class II recall, and the company says no patients have been harmed. For an Indian pharma firm navigating the demanding US market, the optics matter as much as the classification.
Key Takeaways
Shilpa Medicare initiated a voluntary recall of 27,923 vials of Pemetrexed Injection (Pemetri RTU) in the US on 29 July 2026 .
The recall covers four batches — two each of the 100 mg/10 mL and 500 mg/50 mL strengths.
Affected vials showed green to dark green discolouration , outside the approved appearance specification.
The US FDA classified the action as a Class II hospital-level recall .
No adverse events have been reported in connection with the affected batches.
The company does not expect any material financial or operational impact from the recall.
Shilpa Medicare Limited has voluntarily recalled 27,923 vials of Pemetrexed Injection (Pemetri RTU) from the United States market, citing atypical discolouration in the affected batches. The recall, initiated on 29 July 2026, covers both the 100 mg/10 mL and 500 mg/50 mL formulations and operates at the retail and hospital level.
What Triggered the Recall
The affected product displayed green to dark green discolouration, which falls outside the drug's approved appearance specification. The approved specification describes Pemetri RTU as a clear, colourless to pale yellow to green-yellowish solution. The deviation prompted the company to act as a precautionary measure, in consultation with the US Food and Drug Administration (US FDA).
Scope and Classification
The recall covers four batches — two batches of each strength. Of the total affected quantity, 18,434 are 10 mL vials and 9,489 are 50 mL vials. The US FDA has classified the action as a Class II hospital-level recall, which typically indicates a situation where the product may cause temporary or medically reversible adverse health consequences, but where the probability of serious harm is remote.
No Adverse Events Reported
Shilpa Medicare stated that no adverse events have been reported in connection with the affected batches. The company emphasised that the recall is strictly limited to the four identified batches and does not affect any other products, its manufacturing arrangements, or supply commitments to customers.
Financial and Operational Impact
According to a stock exchange filing, the company does not expect the recall to have any material impact on its financial position or operations. Notably, the recall comes months after Shilpa Medicare's wholly-owned subsidiary, Shilpa Biologicals Private Ltd (SBPL), signed a co-development and supply agreement with Finland-based Orion Corporation for an intravenous nivolumab biosimilar targeting the European market. Under that agreement, SBPL will manufacture and exclusively supply the biosimilar from its biologics facility in Dharwad, Karnataka, while Orion holds exclusive rights to register and sell the product across Europe.
The voluntary recall underscores the heightened regulatory scrutiny Indian pharmaceutical exporters face in the US market, where Class II actions — though less severe than Class I — still require swift corrective response and public disclosure.
Point of View
But it is a signal. Discolouration in an injectable oncology drug — one used in lung and pleural cancer treatment — is the kind of quality deviation that erodes trust with US hospital procurement teams, who have long memories. Shilpa Medicare's disclosure is timely and its 'no material impact' assurance may well hold, but Indian pharma's US credibility has been built painstakingly after years of FDA import alerts against peers. Each voluntary recall, however well-managed, adds to the scrutiny burden. The more consequential question is whether the root cause — contamination, storage, formulation instability — has been fully resolved, not just disclosed.
NationPress
18 Aug 2026
Frequently Asked Questions
Why has Shilpa Medicare recalled Pemetrexed injection vials in the US?
Shilpa Medicare recalled 27,923 vials of Pemetrexed Injection (Pemetri RTU) because the affected batches displayed green to dark green discolouration, which is inconsistent with the drug's approved appearance specification. The recall was initiated voluntarily on 29 July 2026 as a precautionary measure in consultation with the US FDA.
What is a Class II recall and how serious is it?
A Class II recall, as classified by the US FDA, indicates that the product may cause temporary or medically reversible adverse health consequences, but the probability of serious harm is considered remote. It is less severe than a Class I recall, which involves products that could cause serious health consequences or death.
How many vials and which batches are affected by the Shilpa Medicare recall?
The recall covers 27,923 vials across four batches — two batches each of the 100 mg/10 mL and 500 mg/50 mL strengths. Of the total, 18,434 are 10 mL vials and 9,489 are 50 mL vials. No other products or batches are affected.
Have any patients been harmed by the recalled Pemetrexed vials?
No. Shilpa Medicare has stated that no adverse events have been reported in connection with the affected batches as of the time of disclosure.
Will the recall affect Shilpa Medicare's finances or operations?
The company has said it does not expect the recall to have any material impact on its financial position, operations, or other affairs. The recall is limited to four batches and does not disrupt its broader manufacturing or supply arrangements.
