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Drug FDA Class II Ongoing Failed specifications

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

Acella Pharmaceuticals, LLC Published Oct 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 Acella Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

Hazards

Failed Dissolution · primary

Affected products (1)

Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

DOXYCYCLINE · 4,680 500-count bottles

NDC: 42192-501, 42192-501-50, 42192-501-05
Code info: Lot #: P24ZLK1, Exp 5/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 29, 2025
  2. Published
    Oct 15, 2025
Recall number
D-0014-2026
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.