Gabapentin Capsules Nationwide Recall for Failed Impurity Specifications
The Harvard Drug Group LLC is recalling Gabapentin Capsules (100 mg) distributed nationwide due to out-of-specification impurity results detected during routine stability testing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II drug recall for an unknown impurity detected during routine stability testing. This represents a potential risk of harm in a prescription medication; the hazard was identified through quality control testing.
Plain-English summary
The Harvard Drug Group LLC, through its packager Major Pharmaceuticals, is recalling Gabapentin Capsules, USP, 100 mg, in 100-count packages (10 x 10 blister packs). The affected products are identified by NDC 0904-6665-61, NDC 0904-6666-61, and NDC 0904-6667-61. Distribution was nationwide across the United States.
The recall was initiated due to failed impurity specifications discovered during routine stability testing. An out-of-specification result was obtained for the Highest Unknown Impurity. This quality control finding indicates the presence of an unidentified chemical compound that does not meet the product's established specifications.
The recall affects the following lot numbers with their respective expiration dates: Lot M04950 (01/2026), Lots M04989 and M04990 (02/2026), Lot M05056 (04/2026), Lot M05150 (07/2026), Lot M05290 (11/2026), Lots M05312 and M05342 (01/2027), and Lots M05369 and M05386 (02/2027).
Patients should not use Gabapentin from the affected lots and should contact their healthcare provider or pharmacist for alternative treatment options or replacement medication. Healthcare providers should review patient records to identify patients dispensed these affected lot numbers.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Prescription
- Hazard
- unknown-impurity
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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.
Distribution
Distributed nationwide across the United States.
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