Food, drugs, devices › The Harvard Drug Group LLC
Drug recall: Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar
The Harvard Drug Group LLC (Dublin, OH) initiated this drug recall on 10 Oct 2025; FDA lists 2 product records under event 97777, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. The Harvard Drug Group LLC has 8 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 LLC, Dublin, OH.
Reason for recall
"Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity ."
Distribution
"US Nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0030-2026 | Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 | — | Class II | Ongoing | 29 Oct 2025 |
| D-0031-2026 | Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag). | — | Class II | Ongoing | 29 Oct 2025 |
Context
Other enforcement events for The Harvard Drug Group LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Jun 2026 | Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distribut | Drug | Class II | 1 |
| 9 Apr 2026 | Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac | Drug | Class II | 1 |
| 24 Mar 2026 | Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Di | Drug | Class II | 1 |
| 17 Feb 2026 | Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Maj | Drug | Class II | 1 |
| 19 Jun 2025 | Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO | Drug | Class II | 2 |
| 10 Jun 2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., | Drug | Class II | 1 |
| 31 Dec 2014 | Thera Tablets with Beta Carotene Dietary Supplement | Food | Class III | 1 |
All 8 events for The Harvard Drug Group LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity ."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.