Gabapentin 600 mg Tablets Recalled Due to Metformin Contamination
Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.
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 recall with no reported illnesses or injuries. Contamination of Metformin ER tablets in Gabapentin bottles presents a risk-of-harm situation through potential unintended medication exposure, meeting the criterion for high-severity recalls without documented injury.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets, USP, 600 mg, supplied in 500-count bottles. Three fused tablets of Metformin ER 500 mg were found in a bottle of Gabapentin, prompting this nationwide recall. Lot 1380040A (Exp. July 31, 2025) is affected.
The presence of foreign tablets in a medication bottle may result in patients taking unintended medication.
A total of 11,808 bottles have been recalled. The affected product was distributed nationwide in the United States.
If you have this medication, check your bottle for the recalled lot number (1380040A). Do not use the product if you find foreign tablets. Contact your pharmacy or healthcare provider for instructions on returning the product.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- Granules Pharmaceuticals Inc.
- Hazard
- foreign-tablets
- medication-error
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 (3)
- Lot 1380040A
- Exp. date July 31
- 2025
UPCs (2)
- 0370010228016
- 0370010227019
Distribution
Distributed nationwide across the United States.
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