Multi-event July 2026 FDA Recall Pemrydi Rtu by Shilpa Medicare Limited
This Multi-event Class II drug recall was voluntarily initiated by Shilpa Medicare Limited on July 29, 2026 for the product Pemrydi Rtu. The FDA reported the reason for recall as discolored solution. the firm has received market complaints reporting green to dark green discoloration in certain vials. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0764-2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
07-29-2026
08-26-2026
18,434 10mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Shilpa Medicare Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0765-2026
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
07-29-2026
08-26-2026
9,489 50mL vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Shilpa Medicare Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
