FDA recall D-0764-2026

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

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2026-07-29

Report date

2026-08-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jadcherla, Mahabubnagar District, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0764-2026