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

FDA recall notice · announced October 15, 2025 · Acella Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: P24ZLK1, Exp 5/31/2027
Quantity: 4,680 500-count bottles
Status: Ongoing
Products in this recall event:
- Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05. (D-0014-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.