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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

Irbesartan Tablets Recalled Due to Failed Dissolution

Agency Publication Date: July 26, 2022
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Summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 38,160 bottles of Irbesartan (75mg and 150mg), a medication used to treat high blood pressure and kidney disease in patients with type 2 diabetes. The recall was initiated because the tablets failed dissolution specifications, meaning they may not dissolve properly in the body. The products were manufactured in India and distributed to pharmacies nationwide across the United States.

Risk

If the medication fails to dissolve as designed, the patient may not receive the intended therapeutic dose. This could lead to poorly controlled blood pressure or inadequate treatment of kidney issues. No incidents or injuries have been reported to date regarding this issue.

What You Should Do

  1. The recalled products are 90-count bottles of Irbesartan Tablets, USP, in 150mg (NDC 59746-448-90) and 75mg (NDC 59746-447-90) strengths. Affected lots include IB220023A, IB120012A, IB120013A, and IB120014A with expiration dates of August 2022.
  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 Jubilant Cadista Pharmaceuticals, Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

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, 150mg, 90-count bottles
Variants: 150mg, Tablet, Rx only
Lot Numbers:
IB220023A (Exp 08/2022)
NDC:
59746-448-90

Recall #: D-1293-2022; Manufactured by Jubilant Generics Ltd. Roorkee, India.

Product: Irbesartan Tablets, USP, 75 mg, 90-count bottle
Variants: 75mg, Tablet, Rx only
Lot Numbers:
IB120012A (Exp 08/2022)
IB120013A (Exp 08/2022)
IB120014A (Exp 08/2022)
NDC:
59746-447-90

Recall #: D-1294-2022; Manufactured by Jubilant Generics Ltd. Roorkee, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90610
Status: Resolved
Manufacturer: Jubilant Cadista Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (9,600 bottles; 28,560 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 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.