Midodrine Hydrochloride Tablets recall
FDA recall D-0383-2026 · initiated Feb 17, 2026
The Harvard Drug Group LLC recalled Midodrine Hydrochloride Tablets in Feb 2026 — an FDA Class II recall (D-0383-2026) because Defective container; inadequately sealed blister packaging.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container; inadequately sealed blister packaging.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8892 cartons
Details
- Product
- Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide US.
- Initiated
- Feb 17, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Midodrine Hydrochloride Tablets recalled?
- The Harvard Drug Group LLC recalled Midodrine Hydrochloride Tablets in Feb 2026 — an FDA Class II recall (D-0383-2026) because Defective container; inadequately sealed blister packaging. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Midodrine Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0383-2026 was: Defective container; inadequately sealed blister packaging.
- Is a recalled Midodrine Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Midodrine Hydrochloride Tablets are affected?
- Distributed: Nationwide US.. The recall covers these lots — Lot # N02640, Exp Date: 08/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0383-2026.