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Drug FDA Class III Ongoing Chemical

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Guja

SUN PHARMACEUTICAL INDUSTRIES INC Published Apr 16, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Cross Contamination

Hazards

Cross Contamination · primary

Affected products (1)

Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.

GABAPENTIN · 852 bottles

NDC: 62756-137, 62756-138, 62756-139, 62756-202, 62756-204, 62756-137-02, 62756-137-03, 62756-137-05, 62756-137-04, 62756-137-01, 62756-138-02, 62756-138-03, 62756-138-05, 62756-138-04, 62756-138-01, 62756-139-02, 62756-139-03, 62756-139-05, 62756-139-04, 62756-139-01, 62756-202-01, 62756-202-03, 62756-204-01, 62756-204-03
Code info: Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Mar 4, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0312-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.