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Drug FDA Class II Ongoing Foreign material

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

Amerisource Health Services LLC Published Jan 15, 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 Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Foreign Tablets/Capsules

Hazards

Foreign Tablets/Capsules · primary

Affected products (1)

Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21

CLOBAZAM · 5,178 cartons

NDC: 60687-423, 60687-423-11, 60687-423-21
Code info: Lot #: 1019594, Exp. Date 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Dec 13, 2024
  2. Published
    Jan 15, 2025
Recall number
D-0184-2025
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.