Shilpa Medicare Limited Pemrydi RTU , 100 mg/10 mL , Single-dose vial recall: Discolored solution. The firm has received market complaints reporting green
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
The hazard: Drug safety concern
The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
What the notice says: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.
Recall details
- Recall number
- D-0764-2026
- Published
- August 26, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Shilpa Medicare Limited
- Product type
- Prescription & OTC drugs
- Units affected
- 18,434 10mL vials
- Distribution
- Nationwide
- Made in
- India
- Lot / code info
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
Products covered by this recall
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
Check your product
The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- P400172
- PA00050A
- Exp 09
- 30
- 2027 — 18
- 434 10mL vials
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 09
- 30
- 2027 — 18
- 434 10mL vials
NDC number
On the carton and again on the bottle or blister label.
- 70121-2453-1
Package size
Match the net weight or the piece count on the front of the pack.
- 100 mg
- 10 mL
- 10 mg
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Drug safety
Shilpa Medicare Limited — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
- Check the lot number on your pack against the codes listed above.
- Keep the carton; the lot number is often printed only on the outer pack.
- Report side effects you think the product caused to FDA MedWatch.
- Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Shilpa Medicare Limited — Plot No. S20 to S26, Pharmaceutical Formulations SEZ, Jadcherla, Mahabubnagar District
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Shilpa Medicare Limited prescription & otc drugs recalled?
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code P400172, PA00050A, Exp 09; best-by date 09 or 30. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Check the lot number on your pack against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
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