Harvard Drug Group recalls Midodrine tablets due to defective packaging
Harvard Drug Group recalls 50-tablet Midodrine hydrochloride tablets with inadequate blister packaging sealing. This could lead to tablet exposure to moisture or contaminants.
Lower-risk recall
Defective container; inadequately sealed blister packaging.
Contact the company
What happened, in plain English
Harvard Drug Group is recalling 50-tablet Midodrine hydrochloride tablets (5 mg) that have inadequately sealed blister packaging. This defect could allow the tablets to be exposed to moisture or contaminants, potentially affecting their safety and effectiveness. Read more at govinfonow.com/recall/31480-harvard-drug-group-recalls-midodrine-tablets-due-to-defective-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/31480-harvard-drug-group-recalls-midodrine-tablets-due-to-defective-packaging · Updated August 17, 2026 · FDA enforcement record: FDA #D-0383-2026
Cite this page
“Harvard Drug Group recalls Midodrine tablets due to defective packaging.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31480-harvard-drug-group-recalls-midodrine-tablets-due-to-defective-packaging. Based on FDA recall #D-0383-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0383-2026%22&limit=1).
Why it’s dangerous
The blister packaging is not sealed properly, which could allow moisture or contaminants to enter the tablets. This might affect the tablets' stability and effectiveness, but does not pose an immediate risk of injury or serious harm.
Who’s affected
Prescription users of Midodrine hydrochloride tablets who received the recalled lot (N02640) from Harvard Drug Group. Those with the specific packaging and expiration date are most at risk.
How to tell if you have this one
Check for the product name 'Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets' in 5 x 10 blister packs. The lot number N02640 and expiration date 08/2027 are specific identifiers for this recall.
- Brand
Harvard Drug Group- Category
Drug
What to do — step by step
Check Packaging
Verify the lot number N02640 and expiration date 08/2027 on the blister packs.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide US.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0383-2026 (February 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0383-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.