Acella Pharmaceuticals recalls doxycycline hyclate tablets, 100 mg, 500-count bottles distributed nationwide in the USA. Stability testing found the lot did not meet dissolution specifications. Consumers and healthcare providers should stop using the product immediately and contact Acella for guidance.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Consumers and healthcare providers should stop using this product immediately. Contact Acella Pharmaceuticals, LLC or your healthcare provider for guidance. Notification method: Letter
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Doxycycline hyclate is a broad-spectrum antibiotic used to treat infections. The product in question is a 100 mg tablet, distributed nationwide as a prescription medication.
The dissolution failure means the drug may not dissolve as expected in the body, potentially reducing efficacy. This can lead to suboptimal treatment outcomes if the patient relies on the tablet for infection control.
This recall is not described as part of a broader industry pattern in the available information.
Patients with the affected lot may experience reduced therapeutic effect. The recall emphasizes stopping use and seeking guidance from healthcare providers.
Refer to the FDA enforcement page for D-0014-2026 and contact Acella Pharmaceuticals for instructions
Remedies typically involve replacement or refund as directed by the manufacturer; processing timelines vary by pharmacy and provider
Keep the recall notice, bottle labels showing NDC and lot, and all correspondence with the manufacturer and healthcare providers
NDC 42192-501-05; Lot P24ZLK1; Exp 5/31/2027; Quantity 4,680 bottles; Bottle count 500 per bottle; Distribution Nationwide in the USA; Rx Only; Sold through healthcare providers; Price not disclosed.
No injuries or incidents have been reported.
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