FDA Drugs recall ·
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only… recall
- Recall number
- D-0014-2026
- Date
- (initiated September 29, 2025)
- Company / brand
- Acella Pharmaceuticals, LLC
1880 Mcfarland Pkwy Ste 110, Alpharetta, GA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,680 500-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Why was it recalled?
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: P24ZLK1, Exp 5/31/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0014-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.