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
USPEMRYDI 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
Recalling Firm: Shilpa Medicare Limited
Reason for Recall / Hazard
TranslatedDiscolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Product Description & Identification
TranslatedPEMRYDI 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
Affected Products
TranslatedPEMRYDI 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
Additional Source Details
| Field | Value |
|---|---|
| City | Jadcherla, Mahabubnagar District |
| Openfda › Upc › 1 | 0370121246213 |
| Openfda › Upc › 2 | 0370121246114 |
| Openfda › Upc › 3 | 0370121245315 |
| Openfda › Unii | F4GSH45R4C |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 2637958 |
| Openfda › Rxcui › 2 | 2637964 |
| Openfda › Rxcui › 3 | 2637966 |
| Openfda › Rxcui › 4 | 2637967 |
| Openfda › Rxcui › 5 | 2637968 |
| Openfda › Rxcui › 6 | 2637969 |
| Openfda › Spl id | b6a00be1-95d1-4b91-93bf-4430a57eeff6 |
| Openfda › Brand name | PEMRYDI RTU |
| Openfda › Spl set id | 0f006b06-ab85-423d-ba0c-dfc3fc25844e |
| Openfda › Package ndc › 1 | 70121-2453-1 |
| Openfda › Package ndc › 2 | 70121-2461-1 |
| Openfda › Package ndc › 3 | 70121-2462-1 |
| Openfda › Product ndc › 1 | 70121-2453 |
| Openfda › Product ndc › 2 | 70121-2461 |
| Openfda › Product ndc › 3 | 70121-2462 |
| Openfda › Generic name | PEMETREXED DISODIUM |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PEMETREXED DISODIUM HEMIPENTAHYDRATE |
| Openfda › Manufacturer name | Amneal Pharmaceuticals LLC |
| Openfda › Application number | NDA215179 |
| Openfda › Is original packager | true |
| Event id | 99530 |
| Address 1 | Plot No. S20 to S26, Pharmaceutical Formulations SEZ |
| Address 2 | TSIIC Green Industrial Park, Polepally (Village) |
| Code info | Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027 |
| Postal code | N/A |
| Report date | 20260826 |
| Product type | Drugs |
| Product quantity | 9,489 50mL vials |
| Reason for recall | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260729 |
| Initial firm notification | Letter |
| Center classification date | 20260814 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesci...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Check Other Products In Your Household
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Overview
- Recalling FirmShilpa Medicare Limited
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.
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🚨 SAFETY ALERT: Shilpa Medicare Limited - 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 Check if your household is affected: https://therecallfile.com/recalls/pemrydi-rtu-pemetrexed-injection-500-mg-50-ml-10-mg-ml-single-dose-via/FDA-D-0765-2026
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