FDA Recall D-0014-2026
Acella Pharmaceuticals, LLC · Alpharetta, GA
Class II Ongoing 227 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0014-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-09-29
- Classified by FDA Center
- 2025-10-09
- FDA published
- 2025-10-15
- Recalling firm
- Acella Pharmaceuticals, LLC
- Firm location
- Alpharetta, GA
Drug identification
- Brand name(s)
- DOXYCYCLINE
- Generic name(s)
- DOXYCYCLINE HYCLATE
- Manufacturer(s)
- Acella Pharmaceuticals, LLC
- NDC(s)
42192-501- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.