RECALL DATABASE

Doxycycline Recall: Hyclate 100 mg tablets

Announced 2026-05-13 · FDA

FDA recall notice for Doxycycline Hyclate Tablets, USP 100 mg, 500-count Rx bottles distributed nationwide by Acella Pharmaceuticals, LLC (NDC 42192-501-05). The recall is due to failed dissolution specifications found in stability testing for Lot P24ZLK1 (exp 5/31/2027). About 4,680 bottles are affected.

BrandAcella Pharmaceuticals, LLC
ProductDoxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
ReasonFailed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Severitymoderate
Units affected6336
DistributionNationwide in the USA
AgencyFDA
Recall / campaign no.Lot #: P24ZLK1, Exp 5/31/2027

WHAT YOU SHOULD DO

  1. Check if you have Doxycycline Hyclate 100 mg tablets from Acella with Lot P24ZLK1; verify the lot and expiration.
  2. If your bottle is affected, stop using it and contact your healthcare provider or pharmacist for guidance.
  3. Return or dispose of the product according to FDA recall instructions or your pharmacy's guidance.
  4. If you have questions, contact Acella Pharmaceuticals, LLC or the FDA recall information line.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.