FDA recall D-0014-2026

Acella Pharmaceuticals, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-09-29
Report date: 2025-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Alpharetta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0014-2026