PEMRYDI RTU (pemetrexed injection) recall
FDA recall D-0764-2026 · initiated Jul 29, 2026
Shilpa Medicare Limited recalled PEMRYDI RTU (pemetrexed injection) in Jul 2026 — an FDA Class II recall (D-0764-2026) because Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 18,434 10mL vials
Details
- Product
- 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
- Recalling company
- Shilpa Medicare Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Jul 29, 2026
- FDA report date
- Aug 26, 2026
Frequently asked
- Was PEMRYDI RTU (pemetrexed injection) recalled?
- Shilpa Medicare Limited recalled PEMRYDI RTU (pemetrexed injection) in Jul 2026 — an FDA Class II recall (D-0764-2026) because Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was PEMRYDI RTU (pemetrexed injection) recalled?
- Per the FDA enforcement record, the reason for recall D-0764-2026 was: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Is a recalled PEMRYDI RTU (pemetrexed injection) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of PEMRYDI RTU (pemetrexed injection) are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot: P400172; Lot PA00050A, Exp 09/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0764-2026.