Shilpa Medicare US Drug Recall 27,923 Vials

Date: August 18, 2026

Product Recall Details:

Company initiated voluntary recall on July 29, 2026 at retail/hospital level in the United States of America
Total recall quantity: 27,923 vials of Pemetrexed Injection
9,489 vials of 50 mL strength (500 mg/50 mL)
18,434 vials of 10 mL strength (100 mg/10 mL)
Product brand name: Pemetri RTU™
Recall covers 04 batches total: 02 batches of each strength
Reason for recall: Atypical discoloration described as "green to dark green in appearance"
Discoloration not consistent with approved specification for appearance defined as "clear, colorless to pale yellow to green-yellowish solution"
US FDA classification: Class II recall (hospital level)

Impact Assessment:

Recall initiated voluntarily by the Company "out of an abundance of caution"
Conducted in consultation with and according to US FDA procedures
No adverse events reported to the Company regarding affected batches
Recall confined to the specified batches only
Does not affect any other Company products, manufacturing arrangements, or product supply to customers
Company does not foresee any material impact on financial position, operations, or other affairs

Regulatory Context:

Disclosure made under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
Response to news article published in The Economic Times online edition on August 17, 2026
Submitted "in the interest of transparency and to ensure that shareholders and investors at large have correct information"
Intimation hosted on company website at www.vbshilpa.com

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