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

Gabapentin 600mg Tablets Recalled for CGMP Deviations

Glenmark Pharmaceuticals Inc. is voluntarily recalling Gabapentin 600mg tablets (500-count bottles) nationwide due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.

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 recall for CGMP deviations (a manufacturing/quality control deficiency) with no reported illnesses or injuries. Per the rubric, Class II recalls without reported hospitalization or documented harm are typically scored as Moderate (2).

Plain-English summary

Glenmark Pharmaceuticals Inc., USA (located in Mahwah, NJ) is voluntarily recalling Gabapentin 600mg tablets in 500-count bottles distributed nationwide. The recall was initiated on March 13, 2025, and classified by the FDA as Class II on April 8, 2025. The product is manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations discovered during the manufacturing process. The affected product includes multiple lot numbers with expiration dates ranging from April 2025 through October 2026. The affected NDC number is 68462-126-05, with lot numbers including 17231015, 17231128, 17231138, 17231139, 17231143, 17231144, 17231848, 17231898, 17231977, 17231978, 17232015, 17232016, 17232017, 17232034, 17232041, 17232396, 17232406, 17232410, 17232490, 17240326, 17240327, 17240383, 17240395, 17241863, 17241869, 17241870, 17231256, 17231386, 17231387, 17231407, 17231417, 17231418, 17231754, 17240085, 17240117, 17240131.

Consumers who have this product should consult with their healthcare provider or pharmacist regarding whether they are taking affected medication. This is a prescription drug (Rx Only), and patients should not stop taking their medication without medical guidance. Healthcare providers and patients should contact Glenmark Pharmaceuticals Inc. or the FDA with questions or to report any adverse effects.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
  • cgmp-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