Recalls / Class II
Class IID-0014-2026
Product
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
- Brand name
- Doxycycline
- Generic name
- Doxycycline Hyclate
- Active ingredient
- Doxycycline Hyclate
- Route
- Oral
- NDC
- 42192-501
- FDA application
- ANDA210664
- Affected lot / code info
- Lot #: P24ZLK1, Exp 5/31/2027
Why it was recalled
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Recalling firm
- Firm
- Acella Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 110, Alpharetta, Georgia 30005-1795
Distribution
- Quantity
- 4,680 500-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-09-29
- FDA classified
- 2025-10-09
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0014-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.