Medications & Supplements/Prescription Drugs

InvaGen Pharmaceuticals, Inc.: Amlodipine Besylate 10 mg Tablets Recalled for Subpotency

Agency Publication Date: October 11, 2018

Summary

Approximately 2,880 bottles of Amlodipine Besylate (10 mg tablets), a medication used to treat high blood pressure and chest pain, are being recalled because one lot failed stability testing for potency. This means the medication may be less effective than intended, potentially failing to manage a patient's blood pressure or heart condition. The affected product was manufactured by Cipla Ltd. and distributed in 1000-count bottles across the United States.

Risk

The drug is subpotent, meaning it contains less of the active ingredient than required by the product specifications. Taking a subpotent medication for high blood pressure can lead to inadequate control of blood pressure, increasing the risk of cardiovascular events like chest pain or hypertension-related complications.

What You Should Do

Check your medication bottle to see if you have Amlodipine Besylate USP 10 mg Tablets in a 1000-count bottle with UPC 369097128159 and NDC 69097-128-15.
Look for lot number GG80218 with an expiration date of 12/2019 on the bottle label to confirm if your product is part of the recall.
Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking this medication. Do not stop taking your prescribed medication without consulting a professional first.
Return any unused product from the affected lot to your pharmacy for a refund and contact the manufacturer, InvaGen Pharmaceuticals, Inc., for further instructions.
For additional questions, 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

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Amlodipine Besylate USP 10 mg Tablets (1000-count bottles)

Model:

NDC 69097-128-15

UPC Codes:

369097128159

Lot Numbers:

GG80218 (Exp. 12/2019)

Date Ranges: Exp. 12/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81099

Status: Resolved

Manufacturer: InvaGen Pharmaceuticals, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 2880 bottles

Distributed To: Nationwide

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

Risk

What You Should Do

Check your medication bottle to see if you have Amlodipine Besylate USP 10 mg Tablets in a 1000-count bottle with UPC 369097128159 and NDC 69097-128-15.

Look for lot number GG80218 with an expiration date of 12/2019 on the bottle label to confirm if your product is part of the recall.

Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking this medication. Do not stop taking your prescribed medication without consulting a professional first.

Return any unused product from the affected lot to your pharmacy for a refund and contact the manufacturer, InvaGen Pharmaceuticals, Inc., for further instructions.

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