Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
Midodrine Hydrochloride Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective container; inadequately sealed blister packaging.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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, NDC 0904-6818-06.
Affected NDC
0904-6818-06
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Midodrine Hydrochloride NDC 00904-6818 |
5 mg/1 | Tablet Oral |
Major Pharmaceuticals | Rx |
- Recalling firm
- The Harvard Drug Group LLC
- NDC code
- 0904-6818-06
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0383-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by The Harvard Drug Group LLC
All 2026 recalls
Class II · Moderate risk
Omega-3-Acid
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Class II · Moderate risk
Gabapentin Capsules
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Other packaging defect recalls from 2026
All packaging defect recalls
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.