Medications & Supplements/Prescription Drugs

West-Ward Columbus Inc: Doxycycline Hyclate Tablets Recalled for Failed Dissolution Testing

Agency Publication Date: May 26, 2020

Summary

West-Ward Columbus Inc has voluntarily recalled 68,376 bottles of Doxycycline Hyclate Tablets USP (100 mg), an antibiotic medication used to treat various bacterial infections. This recall affects both the 50-count and 500-count bottles distributed nationwide. The recall was initiated because the tablets failed a dissolution test at the end of their shelf life, which means the medication may not break down or absorb into the body correctly as it nears its expiration date. Consumers who have these specific lots should contact their healthcare provider or pharmacist.

Risk

If the medication fails to dissolve properly, the body may not absorb the correct amount of the drug, potentially leading to a lack of efficacy in treating the underlying bacterial infection. There are no reports of injuries or adverse events associated with this recall to date.

What You Should Do

Check your prescription bottle for Doxycycline Hyclate Tablets USP, 100 mg, with NDC 0143-2112-50 (50-count bottle) or NDC 0143-2112-05 (500-count bottle).
Verify the lot numbers and expiration dates on the packaging: for 50-count bottles, look for Lot 71846B (Exp 6/2021); for 500-count bottles, look for Lots 71726A (Exp 6/2020), 71846B (Exp 6/2021), or 71853A (Exp 6/2021).
Contact your healthcare provider or pharmacist immediately to discuss if you should continue taking the medication or if you require a replacement prescription.
Return any unused product to the pharmacy where it was purchased for a refund and contact West-Ward Pharmaceuticals Corp. for further instructions.
For additional questions or to report issues, 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

Consultation and 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 (50-count bottle)

Model:

NDC 0143-2112-50

Lot Numbers:

71846B (Exp 6/2021)

Product: Doxycycline Hyclate Tablets USP, 100 mg (500-count bottle)

Model:

NDC 0143-2112-05

Lot Numbers:

71726A (Exp 6/2020)

71846B (Exp 6/2021)

71853A (Exp 6/2021)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85555

Status: Resolved

Manufacturer: West-Ward Columbus Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 68,376 bottles

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 prescription bottle for Doxycycline Hyclate Tablets USP, 100 mg, with NDC 0143-2112-50 (50-count bottle) or NDC 0143-2112-05 (500-count bottle).

Verify the lot numbers and expiration dates on the packaging: for 50-count bottles, look for Lot 71846B (Exp 6/2021); for 500-count bottles, look for Lots 71726A (Exp 6/2020), 71846B (Exp 6/2021), or 71853A (Exp 6/2021).

Contact your healthcare provider or pharmacist immediately to discuss if you should continue taking the medication or if you require a replacement prescription.

Return any unused product to the pharmacy where it was purchased for a refund and contact West-Ward Pharmaceuticals Corp. for further instructions.

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