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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Amlodipine Besylate Tablets Recalled for Subpotency

Agency Publication Date: July 7, 2023
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Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 3,096 bottles of Amlodipine Besylate Tablets (10 mg), a medication used to treat high blood pressure and chest pain, because the tablets were found to be subpotent during a stability test. The recall affects 1000-count bottles under the Lupin brand with lot number A102887 and an expiration date of June 2023. No incidents or injuries have been reported to date regarding this issue.

Risk

A subpotent drug contains less than the required amount of active ingredient, which may make the medication less effective at managing blood pressure. If blood pressure is not properly controlled, patients may face an increased risk of heart-related complications.

What You Should Do

  1. This recall affects Amlodipine Besylate Tablets, USP 10 mg, sold in 1000-count bottles (NDC 68180-721-03) manufactured by Lupin Limited.
  2. Identify if your product is affected by checking for lot number A102887 with an expiration date of June 2023 (6/2023) on the bottle label.
  3. 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 Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls 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: Amlodipine Besylate Tablets, USP 10 mg (1000-count bottle)by Lupin Pharmaceuticals
Variants: 10 mg, 1000-count bottle, Tablet
Lot Numbers:
A102887 (Exp. 6/2023)
NDC:
68180-721-03

Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD; Manufactured by Lupin Limited, Aurangabad, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92618
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: distributors
Manufactured In: United States, India
Units Affected: 3,096 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 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.