[pending] GABAPENTIN (GABAPENTIN)
Pending LLM rewrite. Source: FDA_DRUG D-0031-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Drugs
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 (14)
- 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.
UPCs (2)
- 0055154336307
- 0055154799201
Distribution
Distributed nationwide across the United States.
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