Pemrydi Rtu Injection
FDA Recall NDC 70121-2462
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Pemrydi Rtu (NDC 70121-2462). A significant event, classified as Class II, was initiated on Jul 29, 2026 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
July 2026 Class II Recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Recall Number
Class II Ongoing
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Jul 29, 2026
Aug 26, 2026
18,434 10mL vials
Recall Profile & Regulatory Data
Event ID
99530
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Shilpa Medicare Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Lot# Lot: P400172; Lot PA00050A, Exp 09/30/2027
Affected Packages Involved in this Recall
70121-2453-1Product
70121-2461-1Product
70121-2462-1Product
July 2026 Class II Recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Recall Number
Class II Ongoing
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Jul 29, 2026
Aug 26, 2026
9,489 50mL vials
Recall Profile & Regulatory Data
Event ID
99530
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Shilpa Medicare Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
PEMRYDI RTU(pemetrexed injection), 500 mg/50 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: 70121-2461-1
Batch or Lot Expiration Information
Lot# Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
Affected Packages Involved in this Recall
70121-2453-1Product
70121-2461-1Product
70121-2462-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
