The Recall Desk
ModerateFDA (Drugs)·D-0320-2025·Announced 2025-04-16

Glenmark Gabapentin 600mg tablets recalled for manufacturing deviations

Glenmark Pharmaceuticals is recalling Gabapentin 600mg tablets nationwide due to manufacturing practice deviations. No illnesses or injuries have been reported in connection with this recall.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II voluntary recall with no reported illnesses, injuries, or adverse events. It was triggered by manufacturing practice compliance issues, which qualifies as a precautionary recall under the FDA classification system.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Gabapentin 600mg tablets in 500-count bottles distributed nationwide due to manufacturing practice deviations. The recall involves multiple lot numbers with expiration dates ranging from April 2025 through October 2026. The affected product has NDC number 68462-126-05.

The manufacturer voluntarily initiated this recall on March 13, 2025. The FDA was notified on April 16, 2025. This is a Class II recall triggered by Current Good Manufacturing Practice (CGMP) deviations. Specific details about the nature of these deviations are not provided in the recall notice.

Gabapentin is a prescription medication. The tablets are manufactured by Glenmark Pharmaceuticals Limited in Pithampur, India and distributed by Glenmark Pharmaceuticals Inc. USA in Mahwah, New Jersey. The affected product was distributed throughout the United States. No illnesses, injuries, or adverse events related to this recall have been reported.

Patients taking Gabapentin from affected lots should consult their healthcare provider or pharmacist before making any changes to their medication. Do not stop taking your medication without medical guidance. Consumers with affected product should return it to their pharmacy for guidance.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug — Prescription
Hazard
  • manufacturing-deviation

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 (20)

  • Lot # 17231015
  • exp. date Apr-25 17231128
  • exp. date Apr-25 17231138
  • exp. date Apr-25 17231139
  • exp. date Apr-25 17231143
  • exp. date Apr-25 17231144
  • exp. date Apr-25 17231848
  • exp. date Aug-25 17231898
  • exp. date Aug-25 17231977
  • exp. date Aug-25 17231978
  • exp. date Aug-25 17232015
  • exp. date Aug-25 17232016
  • exp. date Aug-25 17232017
  • exp. date Aug-25 17232034
  • exp. date Aug-25 17232041
  • exp. date Aug-25 17232396
  • exp. date Nov-25 17232406
  • exp. date Nov-25 17232410
  • exp. date Nov-25 17232490
  • exp. date Nov-25 17240326

UPCs (2)

  • 0368462127018
  • 0368462126011

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · GABAPENTIN

Same category