Shilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
Shilpa Medicare is recalling 9,489 vials of PEMRYDI RTU (pemetrexed disodium) due to reports of green to dark green discoloration in the solution.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a visual defect (discoloration) based on market complaints but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
Shilpa Medicare Limited is recalling 9,489 vials of PEMRYDI RTU (pemetrexed disodium) injection, 500 mg/50 mL (10 mg/mL). The affected product is a single-dose vial intended for intravenous use, manufactured by Zydus Lifesciences Limited in India and distributed by Amneal Pharmaceuticals LC in the United States.
The recall was initiated after the firm received market complaints reporting green to dark green discoloration in certain vials. The affected lots are P400157 (expiration date 08/31/2026) and PA00047A (expiration date 09/30/2027). The product was distributed nationwide in the USA.
Healthcare providers and patients should stop using the affected lots of PEMRYDI RTU and contact their pharmacist or the recalling firm for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- PEMRYDI RTU (PEMETREXED DISODIUM)
- Brand
- PEMRYDI RTU
- Manufacturer
- Shilpa Medicare Limited
- Category
- Drug — Antineoplastic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: P400157
- Exp 08/31/2026
- Lot PA00047A
- Exp 09/30/2027
UPCs (3)
- 0370121246213
- 0370121246114
- 0370121245315
Distribution
Distributed nationwide across the United States.
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