The Recall Desk
ModerateFDA (Drugs)·D-0311-2025·Announced 2025-04-16

Prescription Gabapentin 300 mg Capsules Recalled for Cross Contamination

Sun Pharmaceutical is recalling 12,876 bottles of Gabapentin 300 mg capsules distributed nationwide due to cross contamination. The recall is voluntary and ongoing.

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 III recall initiated voluntarily by the firm. No reported illnesses, deaths, or specific health hazards are mentioned in the source. The recall is precautionary due to cross contamination. FDA Class III recalls are typically scored 1 or 2; without specified high-risk pathogens or reported harm, this is classified as Moderate.

Plain-English summary

Sun Pharmaceutical is recalling Gabapentin 300 mg capsules distributed nationwide due to cross contamination. The recall affects 12,876 bottles with lot numbers HAD1458A (exp. 04/2025), HAD2718A (exp. 07/2025), and HAD3432A (exp. 08/2025).

The firm voluntarily initiated this recall on March 4, 2025. The product is manufactured in Halol, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.

Patients taking medication from these lot numbers should contact their healthcare provider. Pharmacists should not dispense from the affected lots and should return affected product to the supplier.

This recall is ongoing. Consumers should check their medication bottles to verify the lot number and expiration date.

The recalled product

Product
GABAPENTIN (GABAPENTIN)
Brand
GABAPENTIN
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
  • contamination

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 (6)

  • Lot # a) HAD1458A
  • Exp. date 04/2025
  • HAD2718A
  • Exp. date 07/2025
  • b) HAD3432A
  • exp. date 08/2025

UPCs (5)

  • 0362756204010
  • 0362756202016
  • 0362756138025
  • 0362756137028
  • 0362756139022

Distribution

Distributed nationwide across the United States.