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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

MAJOR PHARMACEUTICALS: Doxycycline Hyclate Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: August 2, 2018
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Summary

Major Pharmaceuticals has recalled 3,161 cartons of Doxycycline Hyclate Tablets, USP (100 mg), which is a prescription antibiotic used to treat bacterial infections. The medication was found to fail dissolution specifications, meaning the tablets may not break down and release the active ingredient as designed once swallowed. This defect could lead to decreased effectiveness of the antibiotic treatment, potentially allowing an infection to persist. Consumers who have this medication should contact their healthcare provider or pharmacist and return the product for a refund.

Risk

If the medication fails to dissolve correctly in the digestive tract, the patient may not absorb the full dose of the antibiotic, which could result in treatment failure and the worsening of an underlying infection.

What You Should Do

  1. Check your prescription medication to see if you have Doxycycline Hyclate Tablets, USP, 100 mg, in 30-count unit dose cartons (3 x 10 unit dose cards).
  2. Look for National Drug Code (NDC) 0904-0430-04 on the packaging to confirm if it is the affected product.
  3. Identify if your package belongs to Lot 71545AA with an expiration date of July 2019 (7/2019).
  4. Contact your healthcare provider or pharmacist immediately for guidance and to ensure your medical treatment remains effective.
  5. Return any unused medication from this specific lot to your pharmacy for a refund.
  6. For further information or to report adverse effects, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare 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, Rx Only (30 tablets, 3 x 10 unit dose Cartons)
Model:
NDC: 0904-0430-04
Recall #: D-1026-2018
Lot Numbers:
71545AA (Exp 7/2019)
Date Ranges: 7/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80659
Status: Resolved
Manufacturer: MAJOR PHARMACEUTICALS
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3,161 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 ยท 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.