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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Midodrine Hydrochloride Tablets Recalled for Packaging Defect

Agency Publication Date: March 3, 2026
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Summary

The Harvard Drug Group LLC is recalling 8,892 cartons of Midodrine Hydrochloride Tablets (5 mg), sold under the Major Pharmaceuticals brand. The recall was initiated because the blister packaging may be inadequately sealed or have defective containers, which can compromise the integrity of the medication. Midodrine is a prescription drug used to treat low blood pressure. If you have this medication, you should consult your healthcare provider or pharmacist regarding its use.

Risk

The defective blister seals may expose the tablets to air or moisture, potentially reducing the drug's effectiveness or leading to contamination. This could result in inadequate treatment for patients relying on the medication to manage their blood pressure.

What You Should Do

  1. Check your medication packaging for Major Pharmaceuticals Midodrine Hydrochloride Tablets, USP, 5 mg (50-count cartons containing 5 x 10 blister packs).
  2. Identify if your product is part of the recall by looking for Lot # N02640 with an expiration date of 08/2027 and NDC 0904-6818-06.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Midodrine Hydrochloride Tablets, USP (50 Tablets)by Major Pharmaceuticals
Variants: 5 mg, 5 x 10 blister packs
Lot Numbers:
N02640 (Exp 08/2027)
NDC:
0904-6818-06

Recall # D-0383-2026; Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98456
Status: Active
Manufacturer: The Harvard Drug Group LLC
Sold By: Major Pharmaceuticals
Manufactured In: United States
Units Affected: 8892 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.