Shilpa Medicare Limited — 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 Pharma

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — drug enforcement reference
Source observed: 8/26/2026, 12:00:00 AM UTC
Source updated: 8/26/2026, 12:00:00 AM UTC
Location: Jadcherla, Mahabubnagar District, US
hazard: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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
distribution: Nationwide in the USA.
manufacturer: Shilpa Medicare Limited
recall number: D-0764-2026
source status: Ongoing
classification: Class II
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

Update history (1 recent revisions)