Medications & Supplements/Prescription Drugs

American Health Packaging: Doxycycline Hyclate Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: July 31, 2019

Summary

American Health Packaging has issued a voluntary recall for approximately 6,579 cartons of Doxycycline Hyclate Tablets, USP, 100 mg. This recall affects the 30-tablet cartons containing unit dose blisters used for treating various bacterial infections. The medication is being recalled because it failed dissolution testing, which means the tablets may not dissolve properly in the body to release the active medicine as intended. Consumers who have these specific tablets should contact their healthcare provider or pharmacist for guidance on continuing their treatment.

Risk

If the medication does not dissolve correctly, the patient may not receive the full dose of the antibiotic, potentially leading to ineffective treatment of their bacterial infection. No specific injuries or adverse health consequences have been reported to date.

What You Should Do

Check your medication packaging for Doxycycline Hyclate Tablets, USP, 100 mg (30-tablet cartons) with NDC Carton: 62584-693-21 or NDC Unit Dose: 62584-693-11.
Specifically look for Lot number 172569 with an expiration date of 7/31/2019 printed on the carton or blister pack.
If you identify affected medication, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to ensure your infection is being properly managed.
Return any unused portions of the affected lot to your pharmacy to receive a refund.
Contact American Health Packaging at their Columbus, Ohio facility or via your pharmacy for further instructions regarding the return of these tablets.
For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Doxycycline Hyclate Tablets, USP, 100 mg (30 Tablets per carton)

Model:

NDC Carton: 62584-693-21

NDC Unit Dose: 62584-693-11

Recall #: D-1582-2019

Lot Numbers:

172569 (Exp 7/31/2019)

Date Ranges: Expiration date 7/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83466

Status: Resolved

Manufacturer: American Health Packaging

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 6,579 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Doxycycline Hyclate Tablets, USP, 100 mg (30-tablet cartons) with NDC Carton: 62584-693-21 or NDC Unit Dose: 62584-693-11.

Specifically look for Lot number 172569 with an expiration date of 7/31/2019 printed on the carton or blister pack.

If you identify affected medication, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to ensure your infection is being properly managed.

Return any unused portions of the affected lot to your pharmacy to receive a refund.

Contact American Health Packaging at their Columbus, Ohio facility or via your pharmacy for further instructions regarding the return of these tablets.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.