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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 Irbesartan Tablets Recalled for Dissolution Issues

Agency Publication Date: February 11, 2025
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Summary

AvKARE is recalling 341 cartons of Irbesartan (Irbesartan Tablets USP), 300 mg, a medication used to treat high blood pressure. This recall affects the 50-tablet unit dose cartons because the tablets failed testing for dissolution, which means they may not break down and release the medicine correctly once swallowed. If you have been taking this medication, you should consult with your healthcare provider or pharmacist regarding your treatment.

Risk

If the tablets do not dissolve properly in the digestive tract, the body may not absorb enough of the active medicine. This can lead to poorly controlled blood pressure and an increased risk of health complications related to hypertension.

What You Should Do

  1. This recall affects Irbesartan Tablets USP, 300 mg, sold in unit-dose cartons of 50 tablets (NDC 50268-442-15) with lot number 45279 and an expiration date of 03/31/2025.
  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 (1-888-SAFEFDA) for additional assistance or to report any adverse effects.

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: Irbesartan Tablets USP (300 mg)by AvKARE
Variants: 300 mg, 50 Tablets (5 x 10) Unit Dose per carton
Lot Numbers:
45279 (Exp 03/31/2025)
NDC:
50268-442-15

341 cartons affected

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96172
Status: Active
Manufacturer: AvKARE
Manufactured In: United States
Units Affected: 341 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.