Recall: D-0014-2026

Class II - Potentially Harmful

Class IIClassification

2025-09-29Initiated

OngoingStatus

Acella Pharmaceuticals, LLCFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.