Doxycycline Tablet, Coated
FDA Recall NDC 42192-501
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxycycline (NDC 42192-501). A significant event, classified as Class II, was initiated on Sep 29, 2025 by Acella Pharmaceuticals, Llc. The reported reason for this action was: "Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Sep 29, 2025
Oct 15, 2025
4,680 500-count bottles
Recall Profile & Regulatory Data
Event ID
97716
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# : P24ZLK1, Exp 5/31/2027
Affected Packages Involved in this Recall
42192-501-50Product
42192-501-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
