Why it was recalled
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Product description
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 numbers, UPCs & expiration codes
Lot: P400172; Lot PA00050A, Exp 09/30/2027
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0764-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 29, 2026
- FDA report date
- Aug 26, 2026
- Quantity
- 18,434 10mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shilpa Medicare Limited
Original FDA data
Every field from FDA enforcement report D-0764-2026, exactly as published.
Show all FDA fields
- City
- Jadcherla, Mahabubnagar District
- Status
- Ongoing
- Country
- India
- Event ID
- 99530
- Address
- Plot No. S20 to S26, Pharmaceutical Formulations SEZ
- Address (line 2)
- TSIIC Green Industrial Park, Polepally (Village)
- Code information
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Report date
- Aug 26, 2026
- Product type
- Drugs
- Recall number
- D-0764-2026
- Classification
- Class II
- Recalling firm
- Shilpa Medicare Limited
- Product quantity
- 18,434 10mL vials
- Reason for recall
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jul 29, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2026