FDA recall, , Moderate risk
Major Pharmaceuticals Midodrine Hydrochloride Tablets
Midodrine Hydrochloride Tablets have defective containers and inadequately sealed blister packaging.
Summary by Recall Canary from the FDA notice
What happened
The Harvard Drug Group LLC of Dublin, Ohio, recalled 8892 cartons of 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. The FDA stated the reason as defective container and inadequately sealed blister packaging.
The recall began on February 17, 2026, was added to the FDA's Enforcement Report on March 3, 2026, and was classified by FDA on March 3, 2026. In FDA's weekly enforcement report on March 11, 2026, the recall was listed. The product was distributed nationwide US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets
- NDC
- 0904-6818-06
- Lot code
- N02640
Recall details
- Company began the recall
- Sold in
Nationwide US.
- Company
- The Harvard Drug Group LLCDublin, Ohio
- Hazard
- Packaging defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98456
- Recall number
- D-0383-2026
- Quantity recalled
- 8892 cartons
All recalls from The Harvard Drug Group LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
