Shilpa Medicare recalls
Shilpa Medicare appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-26.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2020-12-16 to 2026-08-26 |
| By agency | FDA Drug (8) |
| By classification | Class II (8) |
| By status | terminated (6), ongoing (2) |
| Distribution named in notices | US |
Recalls
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
FDA Drug · Class II · 2026-08-26 · Shilpa Medicare
Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedab…
FDA Drug · Class II · 2026-08-26 · Shilpa Medicare
Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials - Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactu…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations - Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations - Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations - Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactu…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations - Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic A…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations - Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Reason: CGMP Deviations