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, USP, 60 mg. The affected batch has been identified as Lot 241069C (expiration date May 31, 2027), which includes 165 761 bottles.
- The recall was initiated by Breckenridge Pharmaceutical, Inc due to deviations in Current Good Manufacturing Practice (CGMP) regulations, a quality issue that may cause temporary or medically reversible adverse health consequences.
- Duloxetine delayed-release capsules are used to treat depression, anxiety, fibromyalgia, and chronic pain.
The FDA has issued a Class II recall for duloxetine delayed-release capsules, USP, 60 mg. This medication is manufactured by Towa Pharmaceutical Europe S.L. in Barcelona, Spain. The drug is distributed nationwide, and recalled, by Breckenridge Pharmaceutical, Inc in Berkeley Heights, New Jersey. The recall was initiated on April 21, 2026, and received a Class II classification on May 6, 2026.
The recall was initiated due to CGMP deviations; the product contains high levels of N-nitroso-duloxetine impurity, particularly for Lot 241069C, which expires on May 31, 2027. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is low. Breckenridge Pharmaceutical sent out a public notice via letter; no public press release has been issued for this recall.
Duloxetine delayed-release capsules are a prescription medication used to treat depression and anxiety. It is also used as a pain reliever for fibromyalgia and chronic pain related to nerves, muscles, and bones. Pharmacists should identify and quarantine Lot 241069C, remove it from inventory, and coordinate with prescribers to provide an alternative supply.
Reference
FDA. Enforcement Report. May 13, 2026. Accessed May 13, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219850
