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Drug FDA Class II Ongoing Failed specifications

buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.

Amerisource Health Services LLC Published Jul 17, 2024

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 Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Hazards

Failed Dissolution · primary

Affected products (1)

buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.

BUPROPION HYDROCHLORIDE · 2,484 cartons

NDC: 60687-782, 60687-793, 60687-782-11, 60687-782-01, 60687-793-11, 60687-793-21
Lot codes: 1017343
Code info: Lot 1017343, Exp. 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 24, 2024
  2. Published
    Jul 17, 2024
Recall number
D-0590-2024
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.