Home / Recalls / Shilpa Medicare Limited / D-0764-2026

D-0764-2026 Class II Ongoing

Recalled by Shilpa Medicare Limited — Jadcherla, Mahabubnagar District

FDA drug recall D-0764-2026 was initiated by Shilpa Medicare Limited on July 29, 2026 and is designated Class II. Reason for recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials The recall status is ongoing. Affected quantity: 18,434 10mL vials.

Recall Details

Product Type
Drugs
Report Date
August 26, 2026
Initiation Date
July 29, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,434 10mL vials

Product Description

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 Pattern

Nationwide in the USA.

Code Information

Lot: P400172; Lot PA00050A, Exp 09/30/2027

Other recalls by Shilpa Medicare Limited

  • D-0765-2026 Class II — PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx (July 29, 2026)
  • D-0125-2021 Class II — Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shi (December 8, 2020)
  • D-0123-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)
  • D-0124-2021 Class II — Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shi (December 8, 2020)
  • D-0121-2021 Class II — Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be (December 8, 2020)
  • D-0126-2021 Class II — Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx (December 8, 2020)
  • D-0122-2021 Class II — Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only (December 8, 2020)

FDA data resources