FDAClass II · Drug · Recall D-0764-2026 · Recalled August 26, 2026

PEMRYDI RTU (pemetrexed injection) recall — Shilpa Medicare Limited

Agency report date: August 26, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: PEMRYDI RTU (pemetrexed injection)
Company / brand: Shilpa Medicare
Lot / serial / date codes: Lot: P400172; Lot PA00050A, Exp 09/30/2027
Distribution: Nationwide in the USA.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: PEMRYDI RTU (pemetrexed injection) recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0764-2026
Brand: All Shilpa Medicare recalls
Classification: Class II
Units affected: 18,434 10mL vials
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

PEMRYDI RTU (pemetrexed injection) recall status

Companies & origin

Recalling firm location: Jadcherla, Mahabubnagar District, India
Firm address: Plot No. S20 to S26, Pharmaceutical Formulations SEZ, TSIIC Green Industrial Park, Polepally (Village), N/A

Identifying details (verbatim from the notice)

Product codes / lots: Lot: P400172; Lot PA00050A, Exp 09/30/2027
Distribution: Nationwide in the USA.
Firm notified the public via: Letter
FDA event ID: 99530
Recall initiated: July 29, 2026
FDA classified: August 14, 2026
FDA report date: August 26, 2026

Other drug recalls from around the same time

Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · September 2, 2026
Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLCFDA · September 2, 2026
Papaverine HCl Injection recall — American Regent, Inc.FDA · August 26, 2026
Morphine Sulfate Injection recall — Fresenius Kabi USA, LLCFDA · August 26, 2026
Cefazolin in Dextrose recall — Baxter Healthcare CorporationFDA · August 19, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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