Doxycycline Hyclate Tablets Recalled for Failed Dissolution Testing

Acella Pharmaceuticals, LLC, based in Alpharetta, Georgia, has issued a voluntary nationwide recall of one lot of doxycycline hyclate tablets, USP 100 mg packaged in 500-count bottles (NDC 42192-501-05). The recall affects lot P24ZLK1 with an expiration date of May 31, 2027. According to the US Food and Drug Administration (FDA) Enforcement Report, the recall involves approximately 4680 bottles distributed across the United States. The recall was initiated on September 29, 2025, and is currently classified as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The reason for the recall is that stability testing determined the lot failed dissolution specifications, meaning the tablets may not dissolve properly and could potentially deliver less than the intended dose of doxycycline. This type of failure could reduce the drug’s effectiveness, particularly for patients relying on the antibiotic to treat active infections. The company notified distributors and customers via letter and has been coordinating the recall under FDA oversight. No press release has been issued regarding this action, and the recall remains ongoing as of the latest FDA update dated October 9, 2025.

Doxycycline hyclate is a broad-spectrum tetracycline antibiotic commonly prescribed for treating bacterial infections, including respiratory tract infections, skin infections, sexually transmitted infections, and certain types of acne. It is also used as a preventive medication for malaria and for post-exposure prophylaxis in anthrax. Pharmacists should check their inventory for the affected lot and follow recall instructions to ensure removal of the impacted product from distribution and patient access.