The Recall Desk

Manufacturer

Shilpa Medicare Limited

8 recalls in our database name Shilpa Medicare Limited as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
6
Most recent
2026-08-26

Of the 8 recalls from Shilpa Medicare Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (75%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • SevereFDA (Drugs)·D-0764-2026·2026-08-26

    Shilpa Medicare Recalls Discolored Pemetrexed Injection Vials

    Shilpa Medicare is recalling 18,434 vials of PEMRYDI RTU (pemetrexed injection) due to reports of green to dark green discoloration in the solution.

    Product
    PEMRYDI RTU — PEMRYDI RTU (PEMETREXED DISODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0765-2026·2026-08-26

    Shilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials

    Shilpa Medicare is recalling 9,489 vials of PEMRYDI RTU (pemetrexed disodium) due to reports of green to dark green discoloration in the solution.

    Product
    PEMRYDI RTU — PEMRYDI RTU (PEMETREXED DISODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0125-2021·2020-12-16

    FDA Recalls Imatinib Mesylate Tablets Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 4,166 bottles of Imatinib Mesylate 400 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    IMATINIB MESYLATE — IMATINIB MESYLATE (IMATINIB MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2021·2020-12-16

    Shilpa Medicare Recalls Azacitidine Injection Vials Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 6,560 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and nationwide.

    Product
    Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0126-2021·2020-12-16

    Shilpa Medicare Recalls Docetaxel Injection Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 2,008 vials of Docetaxel Injection USP due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0121-2021·2020-12-16

    Shilpa Medicare Recalls Busulfan Injection Due to Manufacturing Deviations

    Shilpa Medicare Limited is voluntarily recalling 2,064 vials of Busulfan Injection due to CGMP deviations. The recall is nationwide and the lot expired in December 2020.

    Product
    Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726,
    Category
    Drug
    Distribution
    Distributed nationwide