Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Gabapentin Capsules Recalled for Cross Contamination

Agency Publication Date: April 4, 2025

Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 13,728 bottles of Gabapentin (Gabapentin Capsules, USP) in 300 mg and 400 mg strengths. This recall was issued because the capsules may have been subject to cross-contamination during manufacturing. Gabapentin is a prescription medication used to manage seizures and treat nerve pain following shingles.

Risk

Cross-contamination can result in the presence of unintended drug substances in a medication. This poses a risk of unpredictable side effects or allergic reactions if a patient inadvertently consumes a substance not listed on the label.

What You Should Do

This recall affects Sun Pharmaceutical Gabapentin Capsules USP, 300 mg and 400 mg, sold in 500-count and 1,000-count bottles distributed nationwide.
Check your medication bottles for the following identifying lot numbers: for 300 mg capsules, check for lots HAD1458A (Exp. 04/2025), HAD2718A (Exp. 07/2025), or HAD3432A (Exp. 08/2025); for 400 mg capsules, check for lots HAD1712B or HAD1712C (both Exp. 03/2025).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gabapentin Capsules, USP 300 mg

Variants: 300 mg, Capsule

Lot Numbers:

HAD1458A (Exp. 04/2025)

HAD2718A (Exp. 07/2025)

HAD3432A (Exp. 08/2025)

NDC:

62756-138-05

62756-138-04

Packaged in 500-count and 1,000-count bottles.

Product: Gabapentin Capsules, USP 400 mg

Variants: 400 mg, Capsule

Lot Numbers:

HAD1712B (Exp. 03/2025)

HAD1712C (Exp. 03/2025)

NDC:

62756-139-05

62756-139-04

Packaged in 500-count and 1,000-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96415

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (12,876 bottles; 852 bottles)

Distributed To: Nationwide

Agency Last Updated: April 7, 2025

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Sun Pharmaceutical Gabapentin Capsules USP, 300 mg and 400 mg, sold in 500-count and 1,000-count bottles distributed nationwide.

Check your medication bottles for the following identifying lot numbers: for 300 mg capsules, check for lots HAD1458A (Exp. 04/2025), HAD2718A (Exp. 07/2025), or HAD3432A (Exp. 08/2025); for 400 mg capsules, check for lots HAD1712B or HAD1712C (both Exp. 03/2025).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gabapentin Capsules, USP 300 mg

Variants: 300 mg, Capsule

Lot Numbers:

HAD1458A (Exp. 04/2025)

HAD2718A (Exp. 07/2025)

HAD3432A (Exp. 08/2025)

NDC:

62756-138-05

62756-138-04

Packaged in 500-count and 1,000-count bottles.

Product: Gabapentin Capsules, USP 400 mg

Variants: 400 mg, Capsule

Lot Numbers:

HAD1712B (Exp. 03/2025)

HAD1712C (Exp. 03/2025)

NDC:

62756-139-05

62756-139-04

Packaged in 500-count and 1,000-count bottles.