Class II · Moderate risk
Memantine Hydrochloride Extended-Release
Failed Dissolution Specifications
Memantine Hydrochloride Extended-Release Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Affected NDC
0904-6735-61
Compare with the code on your package — it is the most precise check available.
Drug: Memantine
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 |
|---|---|---|---|---|
| memantine hydrochloride NDC 00904-6735 |
28 mg/1 | Capsule, Extended Release Oral |
Major Pharmaceuticals | Rx |
- Recalling firm
- The Harvard Drug Group
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1262-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Memantine recalls
See all
Class II · Moderate risk
Namzaric (memantine HCl extended release and donepezil HCl)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Memantine Hydrochloride Extended Release Capsules
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Other recalls by The Harvard Drug Group
All 2020 recalls
Class II · Moderate risk
Carton Label: MAJOR
Subpotent Drug
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
Midodrine Hydrochloride Tablets
Defective container; inadequately sealed blister packaging.
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