Nationwide Recall of Isotretinoin Capsules Issued Over Dissolution Failure

Mylan Pharmaceuticals Inc has initiated a voluntary nationwide recall of isotretinoin capsules, USP 40 mg, packaged in 3 x 10-count prescription blister packs (NDC 0378-6614-93). The product, manufactured for Mylan Pharmaceuticals Inc, Morgantown, West Virginia, and made in France, is being recalled at the blister-pack level. A total of 34 850 blister packs are affected. The recall applies to lot numbers 3116110 and 3116130, with an expiration date of July 2026. The firm notified consignees via letter. The recall was initiated on February 24, 2026, and remains ongoing. Distribution occurred nationwide within the US.

The reason for the recall is failure to meet dissolution specifications, a quality control issue that could potentially affect the rate and extent of drug release. At the time of posting in the US Food and Drug Administration (FDA) Enforcement Report (event ID 98477), the recall has not yet been classified by the FDA. No press release has been issued. The action was voluntary and firm-initiated, and there is no termination date currently listed.

The recalling firm, Mylan Pharmaceuticals Inc, is responsible for the action. Pharmacists should review inventory for the affected lot numbers and follow recall instructions provided in the notification letter. Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in patients who have not responded adequately to conventional therapy, including systemic antibiotics, and it is subject to strict prescribing and dispensing requirements due to its known teratogenic risk.

Reference

FDA. Enforcement Report. February 24, 2026. Accessed March 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218211