CLASS II ONGOING Drug recall · Reported 15 Jul 2026 · FDA Enforcement Report
Pemetrexed for Injection 500mg/Vial-Dose Vial recalled
Reliance Life Sciences Private is recalling Pemetrexed for Injection 500mg/Vial-Dose Vial per, For intravenous use only, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0672-2026
- FDA event ID
- 99312
- Recalling firm
- Reliance Life Sciences Private, Navi Mumbai, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2026
- FDA classified
- 8 Jul 2026
- Reported
- 15 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jun 2026 | Recall initiated by company | |
| 8 Jul 2026 | Classified by FDA | +14 days |
| 15 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Sterility Assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Pemetrexed for Injection 500mg/Vial-Dose Vial per, For intravenous use only recalled?
Yes. Reliance Life Sciences Private recalled Pemetrexed for Injection 500mg/Vial-Dose Vial per, For intravenous use only on 24 Jun 2026. The recall is Class II and its status is Ongoing. Recall number D-0672-2026.
Why was it recalled?
Lack of Sterility Assurance
Which lots are affected?
Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Reliance Life Sciences Private
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azacitidine for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS II | Pemetrexed for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
| Drug | CLASS II | Bortezomib for Injection 5mg/Vial per Single-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |
Other Pemetrexed recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pemetrexed for Injection 100mg/Vial-Dose Vial recalled | Reliance Life Sciences Private | Sterility | Nationwide |