Midodrine Hydrochloride Tablets, 5 mg, 50 tablets in 5 x 10 blister packs, distributed nationwide by Major Pharmaceuticals, are recalled. The packaging defect involves inadequately sealed blister packaging. Healthcare providers and patients should stop using the product immediately and contact The Harvard Drug Group LLC for guidance.
Defective container; inadequately sealed blister packaging.
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance. Notification method: Letter
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Midodrine hydrochloride is a prescription medication used to treat orthostatic hypotension by increasing blood pressure. It is supplied in tablet form for oral administration.
A defective blister packaging can compromise drug integrity and may lead to contamination or reduced potency if used.
This recall is not part of a broader industry pattern.
The recall affects 8,892 cartons nationwide. Healthcare providers and patients should stop using the product immediately and seek guidance from The Harvard Drug Group. No injuries or deaths are reported in the notice.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0383-2026
Recall notice indicates disposition by letter from the Harvard Drug Group; exact refund/replacement timelines are not specified.
Keep recall notice, packaging, lot numbers, and all correspondence with the provider and distributor for records
Product: Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs)\nNDC: 0904-6818-06\nLot: N02640\nExp: 08/2027\nRecall quantity: 8,892 cartons\nSold/distributed: Nationwide US\nDistributor/packager: Major Pharmaceuticals, Indianapolis, IN 46268 USA\nRecall date: 2026-02-17\nStatus: ACTIVE\nClassification: Class II
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