Pemetrexed for Injection recalled due to lack of sterility assurance
Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/Vial nationwide due to lack of sterility assurance. The affected product may not meet required sterility standards for intravenous use.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug with a lack of sterility assurance. Intravenous medications that do not meet sterility standards pose serious risk of infection and other adverse health consequences, meeting the Severe classification threshold.
Plain-English summary
Reliance Life Sciences Private Limited is recalling Pemetrexed for Injection 500mg/Vial (NDC 70069-0835-01), manufactured for Somerset Therapeutics, LLC, due to lack of sterility assurance. Approximately 5,020 vials have been distributed nationwide in the USA.
The affected lots are: RPTH0125A (expiry January 31, 2028), RPTH0225A (expiry January 31, 2028), RPTH0325A (expiry January 31, 2028), and RPTH0725A (expiry April 30, 2028). Each carton contains one 50 mL single-dose vial for intravenous use only.
Healthcare providers and patients who have received this product should contact their healthcare provider or pharmacy. Patients should not use the recalled product and should seek medical guidance regarding their current therapy. The product is prescription-only and should only be handled by licensed healthcare professionals.
The recalled product
- Product
- 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
- Manufacturer
- Reliance Life Sciences Private Limited
- Category
- Drug — Injectable / Intravenous
- Affected units
- 5,020
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot
- expiry: RPTH0125A Jan 31
- 2028
- RPTH0225A Jan 31
- RPTH0325A Jan 31
- RPTH0725A Apr 30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Reliance Life Sciences Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Reliance Life Sciences Private Limited
See all →- SevereBortezomib for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
Same hazard · lack of sterility
See all →- SevereK.C. Pharmaceuticals Recalls Dry Eye Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Multiple Brands of Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereGentle Eyes Lubricant Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
Similar recalls
- HighSemaglutide 5 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- HighCompounded Semaglutide Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-09-11
- HighSermorelin Acetate Injection Recalled Due to Sterility Assurance Issues
FDA (Drugs) · 2022-04-27
- HighCompounded semaglutide vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05
- SeverePromise Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns
FDA (Drugs) · 2019-02-20
- HighSemaglutide 10 mg vials recalled for lack of sterility assurance
FDA (Drugs) · 2025-11-05