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.
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
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.
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.
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.
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.
Look for the lot numbers on the blister pack and outer bag: M04989A, M05056A, M05150A, or M05312A.
The recall notice does not specify the exact impurity. It mentions an 'out of specification result' for a 'highest unknown impurity' from stability testing.
Check the lot numbers on the blister pack and outer bag: M04989A (exp 02/2026), M05056A (exp 04/2026), M05150A (exp 07/2026), or M05312A (exp 01/2027).
The recall does not provide a remedy, so there is no specific instruction to stop using or discard the product.
We’ve drafted a message you can send Harvard Drug Group to request your refund or repair — edit it as you like.
Subject: Recall D-0031-2026 — Harvard Drug Group Harvard Drug Group Hello, I own a Harvard Drug Group that is covered by recall D-0031-2026 from Harvard Drug Group. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
