Medications & Supplements/Prescription Drugs

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

Agency Publication Date: June 8, 2020

Summary

American Health Packaging is recalling approximately 15,755 cartons of Doxycycline Hyclate Tablets (100 mg), a prescription antibiotic used to treat bacterial infections. The recall was initiated because testing at the end of the drug's shelf life showed it failed to dissolve properly, reaching only 59% dissolution compared to the required 85%. The affected products include 30-count cartons (three strips of 10 tablets) with specific expiration dates through January 2021. Because the medication may not dissolve as intended in the body, patients may receive a lower-than-expected dose, which can impact the effectiveness of the treatment.

Risk

If the tablets fail to dissolve correctly in the digestive system, the body cannot absorb the full amount of the antibiotic. This could result in ineffective treatment of a bacterial infection, potentially allowing the illness to persist or worsen.

What You Should Do

Check your medication packaging to see if you have Doxycycline Hyclate Tablets, 100 mg, distributed by American Health Packaging.
Verify the lot numbers and expiration dates on your carton or unit dose packaging. Affected lots are 179605 (Exp 06/30/2020), 181105 (Exp 08/31/2020), and 183019 (Exp 01/31/2021).
Confirm the National Drug Code (NDC) matches NDC 62584-693-21 for the carton or NDC 62584-693-11 for the unit dose packaging.
If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
Return any unused medication to the pharmacy where you purchased it for a refund.
Contact American Health Packaging at their Columbus, Ohio office for further information regarding this recall.
For additional consumer safety questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Lot Numbers:

179605 (Exp 06/30/2020)

181105 (Exp 08/31/2020)

183019 (Exp 01/31/2021)

Date Ranges: Exp 06/30/2020, Exp 08/31/2020, Exp 01/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85745

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 15,755 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 to see if you have Doxycycline Hyclate Tablets, 100 mg, distributed by American Health Packaging.

Verify the lot numbers and expiration dates on your carton or unit dose packaging. Affected lots are 179605 (Exp 06/30/2020), 181105 (Exp 08/31/2020), and 183019 (Exp 01/31/2021).

Confirm the National Drug Code (NDC) matches NDC 62584-693-21 for the carton or NDC 62584-693-11 for the unit dose packaging.

If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.

Return any unused medication to the pharmacy where you purchased it for a refund.

Contact American Health Packaging at their Columbus, Ohio office for further information regarding this recall.

For additional consumer safety questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.