Shilpa Medicare recall: Pemrydi Rtu and 1 more product
Shilpa Medicare Limited is recalling Pemrydi Rtu and 1 more product – 18,434 10mL vials; 9,489 50mL vials. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 29, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Pemrydi Rtu and 1 more product |
| Brand | Shilpa Medicare |
| Company | Shilpa Medicare Limited |
| Type | Drugs |
| Classification | Class II |
| Recall date | July 29, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 18,434 10mL vials; 9,489 50mL vials |
| Recall ID | 99530 |
Recalled products (2)
- 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
- FDA recall number
- D-0764-2026
- Codes, lots and dates
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Quantity
- 18,434 10mL vials
- Classification
- Class II
- 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
- FDA recall number
- D-0765-2026
- Codes, lots and dates
- Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
- Quantity
- 9,489 50mL vials
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99530
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Jadcherla, Mahabubnagar District, India
Why it was recalled
The reason the FDA lists: “Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide in the USA.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99530, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
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| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Shilpa Medicare Pemrydi Rtu recalled?
Yes. Shilpa Medicare Limited recalled it on July 29, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.