Duloxetine Delayed Release Capsules Recalled Due to CGMP Deviations
Key Takeaways:
- The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for duloxetine delayed release capsules, 30 mg, affecting 50 bottles. The affected batches have been identified as Lots 050725G-30 and 050725F-30 (expiration June 30, 2026).
- The recall was initiated by Asclemed USA, Inc due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Duloxetine is used to treat depression and anxiety. It can also reduce pain caused by diabetic nerve damage and fibromyalgia along with chronic bone and muscle pain.
The FDA has issued a Class II recall for duloxetine delayed release capsules, 30 mg, affecting 50 bottles. This medication is being recalled by Asclemed USA, Inc based in Torrance, California. The recall was initiated on May 14, 2026, and received a Class II classification on June 2, 2026. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or it has a low probability of causing serious adverse health consequences.
The recall was initiated due to CGMP deviations: the product contained levels of nitrosamine that were above acceptable limits. This deficiency affects Lots 050725G-30 and 050725F-30, which will expire on June 30, 2026. Asclemed USA sent out a public notice via letter; no public press release has been issued for this recall.
Duloxetine is a prescription medication used to treat depression and anxiety. It can also be used to relieve pain related to diabetic neuropathy, fibromyalgia, and chronic bone and muscle pain. Pharmacists should identify and quarantine Lots 050725G-30 and 050725F-30, remove them from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. June 10, 2026. Accessed June 10, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220846
