Lower risk Drug recall · FDA · Published July 29, 2026

Shilpa Medicare PEMRYDI RTU: Green discoloration risk in injections

Shilpa Medicare recalls PEMRYDI RTU (pemetrexed injection) due to green discoloration in vials. This may indicate contamination. Check vial color before use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0765-2026Drug Shilpa Medicare ›

Lower-risk recall

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

✎ GovInfoNow plain-language explainer

Shilpa Medicare is recalling PEMRYDI RTU (pemetrexed injection) vials that may have green discoloration. This discoloration could indicate contamination, which might affect treatment safety. Read more at govinfonow.com/recall/692887-shilpa-medicare-pemrydi-rtu-green-discoloration-risk-in-injections.

Source Summary by GovInfoNow · govinfonow.com/recall/692887-shilpa-medicare-pemrydi-rtu-green-discoloration-risk-in-injections · Updated September 14, 2026 · FDA enforcement record: FDA #D-0765-2026

Cite this page

“Shilpa Medicare PEMRYDI RTU: Green discoloration risk in injections.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/692887-shilpa-medicare-pemrydi-rtu-green-discoloration-risk-in-injections. Based on FDA recall #D-0765-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2026%22&limit=1).

The FDA announced on July 29, 2026, that Shilpa Medicare Limited is recalling PEMRYDI RTU pemetrexed injection due to a hazard of discolored solution. Owners should stop using the product immediately.

How to tell if you have it

Brand: Shilpa Medicare
Product: PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only
Manufacturer: Zydus Lifesciences Limited
Distributor: Amneal Pharmaceuticals LC
NDC: 70121-2461-1
Lot codes: P400157 (Exp 08/31/2026) and PA00047A (Exp 09/30/2027)
Quantity: 9,489 vials
Distribution: Nationwide in the USA

The hazard

The firm has received market complaints reporting green to dark green discoloration in certain vials of the recalled pemetrexed injection.

Context

GovInfoNow's records show Shilpa Medicare Limited has one other recall on record since December 8, 2020, involving Busulfan Injection due to CGMP deviations. Other recent recalls of similar products include GE Healthcare Omnipaque 300 mg/mL Injection (March 24, 2026), Reliance Pemetrexed Injection (June 24, 2026), and ProRx Semaglutide Injection (October 15, 2025).

How to tell if you have this one

Check for green to dark green discoloration in the vial. The product is a single-dose vial of pemetrexed injection (500 mg/50 mL) manufactured by Zydus Lifesciences Limited.

Brand
Shilpa Medicare
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA.

Recall number	Product, codes & lots	Quantity
D-0764-2026	PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1; Lot: P400172; Lot PA00050A, Exp 09/30/2027	18,434 10mL vials
D-0765-2026	PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1; Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027	9,489 50mL vials

Based on the official FDA remedy

What to do — step by step

Check Vial Color
Look for green to dark green discoloration in the vial. If present, do not use the product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 28 days after the firm started it.

Jul 29, 2026Firm started the recall
Aug 14, 2026FDA classified it Class II
Aug 26, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/692887-shilpa-medicare-pemrydi-rtu-green-discoloration-risk-in-injections">Shilpa Medicare PEMRYDI RTU: Green discoloration risk in injections (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0765-2026 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0765-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.