Food, drugs, devices › The Harvard Drug Group
Drug recall: Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
FDA enforcement event 85566 is a drug recall by The Harvard Drug Group of Livonia, MI, initiated 24 Apr 2020 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 19 Aug 2022. Initiation: voluntary: firm initiated. The Harvard Drug Group has 21 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Harvard Drug Group, Livonia, MI.
Reason for recall
"Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing."
Distribution
"AL, FL, IA, NY, OH, TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1262-2020 | 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 | 678 cartons | Class III | Terminated | 20 May 2020 |
Context
Other enforcement events for The Harvard Drug Group
All 21 events for The Harvard Drug Group
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "AL, FL, IA, NY, OH, TX"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.