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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

AvKARE Celecoxib Capsules Recalled for Foreign Tadalafil Tablet Contamination

Agency Publication Date: June 9, 2025
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Summary

AvKARE has voluntarily recalled 3,817 cartons of Celecoxib (200 mg) capsules because one Tadalafil (5 mg) tablet was found inside a bottle from the same manufacturing batch. Celecoxib is a prescription medication used to treat pain and inflammation. If a patient accidentally takes Tadalafil instead of Celecoxib, it could cause serious health issues, particularly for individuals who take other medications for heart conditions.

Risk

Taking Tadalafil (the active ingredient in Cialis) unintentionally can cause a dangerous drop in blood pressure. This is especially life-threatening for patients taking prescription nitrates (like nitroglycerin) for chest pain or heart problems.

What You Should Do

  1. This recall affects AvKARE Celecoxib Capsules (200 mg), 50-count unit dose cartons (NDC 50268-169-15), specifically Lot #47881 with an expiration date of 05/31/2026.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Celecoxib Capsules (200 mg)
Variants: 200 mg, Capsule
Lot Numbers:
47881 (Exp 05/31/2026)
NDC:
50268-169-15

3,817 50-count cartons affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96888
Status: Active
Manufacturer: AvKARE
Sold By: Authorized distributors; Retail pharmacies
Manufactured In: United States
Units Affected: 3,817 50-count 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.