Midodrine Hydrochloride Under Class II Recall Due to Inadequately Sealed Blister Packaging

The Harvard Drug Group LLC has initiated a voluntary nationwide recall of midodrine hydrochloride tablets, USP 5 mg, packaged in cartons containing 50 tablets (5 × 10-count blister packs) (NDC 0904-6818-06). The product is packaged and distributed by Major Pharmaceuticals, Indianapolis, Indiana. The recall applies to the blister-pack level. A total of 8892 cartons are affected. The recall applies to lot number N02640, with an expiration date of August 2027. The firm notified consignees via letter. The recall was initiated on February 17, 2026, and remains ongoing. Distribution occurred nationwide within the United States.

The recall is due to a defective container closure caused by inadequately sealed blister packaging, a quality defect that may compromise product integrity. Improperly sealed blisters can expose tablets to moisture or environmental contaminants, potentially affecting stability and potency. The recall has been classified by the US Food and Drug Administration (FDA) as a Class II event (recall number D-0383-2026; event ID 98456), indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse outcomes. No press release has been issued. The action was voluntary and firm-initiated, and there is no termination date currently listed.

The recalling firm, The Harvard Drug Group LLC, Dublin, Ohio, is responsible for the action. Pharmacists should review inventory for the affected lot number and follow recall instructions provided in the notification letter. Midodrine is an alpha-1 adrenergic agonist indicated for the treatment of symptomatic orthostatic hypotension.

Reference

FDA. Enforcement Report. March 11, 2026. Accessed March 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm