Harvard Drug Group Recalls Gabapentin Capsules Due to Impurity Risk
Harvard Drug Group recalls 100mg Gabapentin Capsules (10 per blister) with potential impurities from stability testing. Affected lots expire 02/2026 to 01/2027. No specific remedy provided in recall notice.
Recall notice
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Contact the company
What happened, in plain English
Harvard Drug Group is recalling 100mg Gabapentin Capsules that failed stability testing for unknown impurities. This could pose a risk to users taking the medication, though the exact danger is not specified in the recall notice. Read more at govinfonow.com/recall/31720-harvard-drug-group-recalls-gabapentin-capsules-due-to-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31720-harvard-drug-group-recalls-gabapentin-capsules-due-to-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0031-2026
Cite this page
“Harvard Drug Group Recalls Gabapentin Capsules Due to Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31720-harvard-drug-group-recalls-gabapentin-capsules-due-to-impurity-risk. Based on FDA recall #D-0031-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0031-2026%22&limit=1).
Why it’s dangerous
The capsules failed routine stability testing for an unknown impurity. This could mean the medication contains harmful substances that might affect health, but the exact risk is not clearly described in the recall notice.
Who’s affected
People who have the recalled Gabapentin Capsules (100mg, 10 per blister pack) from the specified lots. Those taking this medication for medical conditions are most at risk.
How to tell if you have this one
Check for the lot numbers: M04989A (exp 02/2026), M05056A (exp 04/2026), M05150A (exp 07/2026), or M05312A (exp 01/2027). The product is a prescription-only 100mg capsule blister pack with NDC numbers 0904-6665-61 and 55154-3363-0.
- Brand
Harvard Drug Group- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| 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; Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027. | — | 0904-6665-61, 0904-6666-61, 0904-6667-61 |
| 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).; Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027. | — | 0904-6665-61, 0904-6666-61, 0904-6667-61, 55154-3363-0, 55154-7992-0, 55154-7993-0 |
What to do — step by step
Check Product Lot Number
Look for the lot numbers on the blister pack and outer bag: M04989A, M05056A, M05150A, or M05312A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 19 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0031-2026 (October 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0031-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.