Major Pharmaceuticals Recalls Midodrine Hydrochloride Tablets Over Packaging Defect
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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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