Quick Facts at a Glance
- Recall Date
- February 17, 2026
- Hazard Level
- HIGH
- Brand
- Midodrine Hydrochloride
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Midodrine Hydrochloride
- Product type
- Midodrine Hydrochloride Tablets
- Model numbers
- Lot N02640
- UPC codes
- 0904-6817, 0904-6818, 0904-6819, 0904-6817-06, 0904-6817-61, 0904-6818-06, 0904-6818-61, 0904-6819-07
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 17, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Defective container; inadequately sealed blister packaging.
What You Should Do
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
About This Product
Midodrine hydrochloride is a prescription medication used to treat orthostatic hypotension by increasing blood pressure. It is supplied in tablet form for oral administration.
Why This Is Dangerous
A defective blister packaging can compromise drug integrity and may lead to contamination or reduced potency if used.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check NDC 0904-6818-06 on the package
- Locate Lot N02640 on the blister or carton
- Verify Expiration Date 08/2027
- If all match, stop using the product and contact the Harvard Drug Group for guidance
Where to find product info
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0383-2026
What timeline to expect
Recall notice indicates disposition by letter from the Harvard Drug Group; exact refund/replacement timelines are not specified.
If the manufacturer is unresponsive
- Document all communications with healthcare providers and the Harvard Drug Group
- File a complaint with the FDA if the company is unresponsive
- Consult your state pharmacy board for additional guidance
How to prevent similar issues
- Verify NDC, lot number, and expiration date before dispensing any medication
- Inspect packaging integrity on receipt of Rx drugs
- Only use medications from approved and licensed pharmacies
- When in doubt, contact a healthcare professional before use
Documentation advice
Keep recall notice, packaging, lot numbers, and all correspondence with the provider and distributor for records
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Product Details
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
Key Facts
- Distributed nationwide in the US
- Defective blister packaging
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