The Recall Desk
HighFDA (Drugs)·D-0031-2026·Announced 2025-10-29

[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.

Related recalls

Same brand · GABAPENTIN

Same category