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FDAFDA · Food and drugs·Recall number D-0014-2026

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

Published October 15, 2025 · Recall initiated: September 29, 2025

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Acella Pharmaceuticals, LLC
Distributor
Nationwide in the USA
Lot
Lot #: P24ZLK1, Exp 5/31/2027
Risk classification
Class II
Area (FDA)
drug
Country
United States

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