Lower risk Drug recall · FDA · Published September 29, 2025

Acella Doxycycline Tablets Recall: Failed Dissolution Testing

Acella Pharmaceuticals recalls 100mg doxycycline tablets due to failed dissolution testing. This may affect medication stability. Check NDC 42192-501-05 and lot P24ZLK1 for affected products.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0014-2026Drug Acella Pharmaceuticals ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmAcella Pharmaceuticals, LLC1880 Mcfarland Pkwy Ste 110 · Alpharetta, GA 30005-1795

✎ GovInfoNow plain-language explainer

Acella Pharmaceuticals is recalling 100mg doxycycline tablets that failed stability testing. This could mean the medication doesn't dissolve properly, potentially affecting effectiveness. The recall applies to specific lots and expiration dates. Read more at govinfonow.com/recall/31764-acella-doxycycline-tablets-recall-failed-dissolution-testing.

Source Summary by GovInfoNow · govinfonow.com/recall/31764-acella-doxycycline-tablets-recall-failed-dissolution-testing · Updated August 17, 2026 · FDA enforcement record: FDA #D-0014-2026

Cite this page

“Acella Doxycycline Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31764-acella-doxycycline-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-0014-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0014-2026%22&limit=1).

The FDA announced on Sept. 29, 2025, that Acella Pharmaceuticals voluntarily recalled Doxycycline Hyclate Tablets due to failed dissolution specifications. The agency issued recall number D-0014-2026 for the Class II product.

How to tell if you have it

Brand: Acella Pharmaceuticals
Product: Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle
NDC: 42192-501-05
Lot #: P24ZLK1
Expiration: 5/31/2027
Quantity: 4,680 bottles

The hazard

Stability testing found that the lot did not meet dissolution specifications. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Acella Pharmaceuticals has issued seven other recalls since May 22, 2020. Recent brand recalls include an April 20, 2026 Naproxen Suspension recall for lead and lithium contamination and a April 24, 2024 Sodium Sulfacetamide Cleanser recall for subpotent drug issues. Other recent recalls of similar products include Ascend Minocycline Tablets Recall (June 1, 2026) and Inventia Chlorthalidone Recall (Sept. 3, 2026).

How to tell if you have this one

Check for the NDC code 42192-501-05 and lot number P24ZLK1 on the product label. The tablets are prescription-only and expire May 31, 2027.

Brand
Acella Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for NDC 42192-501-05 and lot number P24ZLK1 on the tablet packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 16 days after the firm started it.

Sep 29, 2025Firm started the recall
Oct 9, 2025FDA classified it Class II
Oct 15, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Acella Pharmaceuticals recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/31764-acella-doxycycline-tablets-recall-failed-dissolution-testing">Acella Doxycycline Tablets Recall: Failed Dissolution Testing (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0014-2026 (September 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0014-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.