FDAClass IIOctober 15, 2025

Doxycycline Hyclate Tablets recall: Failed Dissolution

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 Doxycycline Hyclate Tablets recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: P24ZLK1, Exp 5/31/2027

Product
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Recalling firm
Acella Pharmaceuticals, LLC
Quantity
4,680 500-count bottles
Distribution
Nationwide in the USA
Recall date
October 15, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls