FDA Drugs recall ·
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL)… recall
- Recall number
- D-0765-2026
- Date
- (initiated July 29, 2026)
- Company / brand
- Shilpa Medicare Limited
Plot No. S20 to S26, Pharmaceutical Formulations SEZ, Jadcherla, Mahabubnagar District, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 9,489 50mL vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0765-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.