← FDA ENFORCEMENT
D-0014-2026Class II

Acella Pharmaceuticals, LLC

Recalling firm
Acella Pharmaceuticals, LLC
Product type
Drug
Status
Ongoing
Report date
2025-10-15
Distribution
Nationwide in the USA
Firm state
GA
Product quantity
4,680 500-count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

Lot #: P24ZLK1, Exp 5/31/2027

Other recalls SPEQ maps to Validation & Qualification
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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.