Methohexital Sodium Injections Recalled Due to Failed Impurities/Degradation Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for methohexital sodium injections, 500 mg. The affected batch has been identified as Lot 7000612A (expires January 2028), affecting 4284 vials.
• The recall was initiated by OneSource Specialty Pharma, Ltd due to failed impurities/degradation specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Methohexital sodium injections are used to sedate patients before surgical procedures.

The FDA has issued a Class II recall for methohexital sodium injections, 500 mg, affecting 4284 vials. This product is manufactured and recalled by OneSource Specialty Pharma, Ltd based in Bengaluru, India. The recall was initiated on June 7, 2026, and received a Class II classification on July 7, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s failure to meet impurities/degradation specifications. This deficiency affects Lot 7000612A, which will expire in January 2028. OneSource Specialty Pharma sent out a public notice via letter; no press release has been issued for this recall.

Methohexital sodium injections are used as anesthetics to induce sedation before surgical procedures to prevent patients from feeling pain or discomfort. Pharmacists should identify and quarantine Lot 7000612A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. July 15, 2026. Accessed July 15, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221084