FDA Class II Recall of Midodrine Hydrochloride Tablets

FDA: Drug Recalls Class II

Filed March 11th, 2026

Detected March 23rd, 2026

Summary

The FDA has announced an ongoing Class II recall for Midodrine Hydrochloride Tablets, USP, 5 mg, initiated by The Harvard Drug Group LLC due to inadequately sealed blister packaging. The recall affects approximately 8,892 cartons distributed nationwide.

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What changed

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Midodrine Hydrochloride Tablets, USP, 5 mg, manufactured by Major Pharmaceuticals and distributed by The Harvard Drug Group LLC. The recall, initiated voluntarily by the firm, is due to defective containers, specifically inadequately sealed blister packaging. The recall number is D-0383-2026, and it affects approximately 8,892 cartons distributed nationwide.

This recall signifies a potential risk to consumers due to compromised product integrity. Compliance officers in the pharmaceutical sector should review their distribution channels and inventory for affected lots (Lot # N02640, Exp Date: 08/2027) and ensure adherence to recall procedures. While this is a voluntary recall, failure to properly manage and report on such actions can lead to further regulatory scrutiny and potential penalties.

What to do next

Review inventory for Midodrine Hydrochloride Tablets, USP, 5 mg, Lot # N02640, Exp Date: 08/2027.
Implement procedures for product quarantine and return/disposal of affected units.
Ensure proper documentation and reporting of recall activities to the FDA.

Source document (simplified)

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