Major Pharmaceuticals Recalls Midodrine Hydrochloride Tablets Over Packaging Defect

Source: FDA · United States

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The Harvard Drug Group LLC is recalling nearly 9,000 cartons of Midodrine Hydrochloride Tablets due to inadequately sealed blister packaging that could compromise the medication.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

The Harvard Drug Group LLC has initiated a voluntary recall of Midodrine Hydrochloride Tablets, USP, 5 mg. The recall was prompted by the discovery of defective containers, specifically inadequately sealed blister packaging. This issue has been classified as a Class II recall by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

Which Products Are Affected

The recall affects the following prescription drug distributed nationwide across the United States:

  • Product Name: Midodrine Hydrochloride Tablets, USP, 5 mg
  • Packaging: 50 Tablets (5 x 10 blister packs) per carton
  • Brand: Major Pharmaceuticals
  • NDC Number: 0904-6818-06
  • Lot Number: N02640
  • Expiration Date: 08/2027
  • Quantity: 8,892 cartons

What You Should Do

Consumers, pharmacists, and healthcare providers are advised to immediately check their inventory for the affected lot number (N02640). If the product is identified, it should be set aside and not used or distributed. The firm initiated the recall through notification letters. For instructions regarding the return or disposal of the affected product, contact The Harvard Drug Group LLC at their Dublin, Ohio location.

Why This Matters

Inadequately sealed blister packaging can compromise the integrity of prescription medication by exposing it to environmental factors, which may lead to drug degradation or contamination.

Source

Information provided by the FDA under recall number D-0383-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The Harvard Drug Group LLC is recalling nearly 9,000 cartons of Midodrine Hydrochloride Tablets due to inadequately sealed blister packaging that could compromise the medication.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.