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Drug FDA Class II Ongoing Failed specifications

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

Graviti Pharmaceuticals Private Limited Published Oct 29, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

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 Graviti Pharmaceuticals Private Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Tablet/Capsule Specifications

Affected products (1)

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.

BUPROPION HYDROCHLORIDE · 46,512/30 count bottles

NDC: 16571-862, 16571-863, 16571-862-03, 16571-862-09, 16571-862-50, 16571-862-10, 16571-862-12, 16571-863-03, 16571-863-09, 16571-863-50, 16571-863-10
Code info: Batch # BPB124341A, Exp date: 10/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 15, 2025
  2. Published
    Oct 29, 2025
Recall number
D-0037-2026
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.