Acella Pharmaceuticals, LLC: Drug Recall

Recall #D-0014-2026 · 09/29/2025

Class II: Risk

Recall Details

Recall Number: D-0014-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Acella Pharmaceuticals, LLC
Status: Ongoing
Date Initiated: 09/29/2025
Location: Alpharetta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,680 500-count bottles

Reason for Recall

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

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.

Distribution Pattern

Nationwide in the USA

Other Recalls by Acella Pharmaceuticals, LLC

Class III: Low Risk 04/24/2024

Subpotent drug
Class III: Low Risk 11/14/2022

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class I: Dangerous 04/29/2021

Subpotent Drug

View all recalls by Acella Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.