Class II U.S. Food and Drug Administration

Shilpa Medicare Limited Pemrydi RTU , 500 mg/50 mL , Single-dose vial recall: Discolored solution. The firm has received market complaints reporting green

Recall published 2 months ago

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

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

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-0765-2026
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
9,489 50mL vials
Distribution
Nationwide
Made in
India
Lot / code info
Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027

Products covered by this recall

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

Check your product

The notice names 20 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.

  • P400157
  • Exp 08
  • 31
  • 2026
  • PA00047A
  • Exp 09
  • 30
  • 2027 — 9
  • 489 50mL vials

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 31
  • 2026
  • 09
  • 30
  • 2027 — 9
  • 489 50mL vials

NDC number

On the carton and again on the bottle or blister label.

  • 70121-2461-1

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg
  • 50 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 — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  3. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  4. Keep the carton; the lot number is often printed only on the outer pack.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

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 P400157, Exp 08, 31; best-by date 08 or 31. 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?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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