Midodrine hydrochloride tablets recalled over inadequately sealed blister packaging
The Harvard Drug Group is recalling one lot of Midodrine Hydrochloride Tablets 5 mg because of a defective container with inadequately sealed blister packaging.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers low-risk, precautionary recalls: the fault is confined to the blister seal protecting the tablets, and the source describes no hazard, illness or injury.
Plain-English summary
The Harvard Drug Group LLC is recalling Midodrine Hydrochloride Tablets USP, 5 mg, in 50-tablet packs (5 x 10 blister packs), prescription only, packaged and distributed by Major Pharmaceuticals of Indianapolis, Indiana, NDC 0904-6818-06. About 8,892 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for a defective container: inadequately sealed blister packaging. The source record does not describe a specific hazard, illness or injury.
Affected product is lot N02640 with an expiry date of 08/2027.
Patients and pharmacies can identify affected product by the NDC, lot number and expiry date above, and may contact The Harvard Drug Group LLC for further information.
The recalled product
- Product
- MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE)
- Brand
- MIDODRINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription tablet
- Affected units
- 8,892
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # N02640
- Exp Date: 08/2027
Distribution
Distributed nationwide across the United States.
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