FDA recall, , Moderate risk
Amneal PEMRYDI RTU (Pemetrexed Injection)
PEMRYDI RTU (pemetrexed injection) has a discolored solution, which can be green to dark green.
Summary by Recall Canary from the FDA notice
What happened
Shilpa Medicare Limited, of Jadcherla, Mahabubnagar District, India, recalled Pemrydi RTU (pemetrexed injection) because of a discolored solution. The firm received market complaints reporting green to dark green discoloration in certain vials. The recall, which began July 29, 2026, covers the 500 mg/50 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) single-dose vials, distributed nationwide in the USA.
The product was manufactured by Zydus Lifesciences Limited, Ahmedabad, India, and distributed by Amneal Pharmaceuticals LC, Bridgewater, NY 08807.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
2 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Pemrydi RTU(pemetrexed injection)
- Strength
- 500 mg
- NDC
- 70121-2461-1
- Lot code
- PA00047A
Pemrydi RTU (pemetrexed injection)
- Strength
- 100 mg
- NDC
- 70121-2453-1
- Lot code
- PA00050A
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Shilpa Medicare LimitedJadcherla, Mahabubnagar District, India
- Hazard
- Quality problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99530
- Recall numbers
- D-0764-2026 to D-0765-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
