Pemetrexed for Injection Recall Due to Sterility Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Reliance Life Sciences Private Limited is recalling 12,000 vials of Pemetrexed for Injection due to lack of sterility assurance. The Class II recall affects specific lots distributed nationwide in the USA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Reliance Life Sciences Private Limited initiated a voluntary recall of Pemetrexed for Injection due to lack of sterility assurance.
Which Products Are Affected
The recall involves Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC: 70069-0834-01. Affected lots include RPTL0325A (exp. Dec 31, 2027), RPTL0425A (exp. Dec 31, 2027), RPTL0624B (exp. Nov 30, 2027), and RPTL0625A (exp. Mar 31, 2028). A total of 12,000 vials are affected. The recall number is D-0671-2026. Distribution was nationwide in the USA.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm or FDA regarding the affected product.
Why This Matters
The recall addresses a potential sterility issue with an injectable oncology medication distributed across the United States.
Source
FDA recall D-0671-2026; https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,052 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.