D-0014-2026 Class II Ongoing
FDA drug recall D-0014-2026 was initiated by Acella Pharmaceuticals, LLC on September 29, 2025 and is designated Class II. Reason for recall: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. The recall status is ongoing. Affected quantity: 4,680 500-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 15, 2025
- Initiation Date
- September 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,680 500-count bottles
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.
Reason for Recall
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: P24ZLK1, Exp 5/31/2027