Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Amlodipine Besylate Tablets Recalled by Lupin Pharmaceuticals Inc. Due to Subpotent Drug: Out-of-Specification test results observed in assay...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lupin Pharmaceuticals Inc. directly.
Affected Products
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03
Quantity: 3,096 bottles
Why Was This Recalled?
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Where Was This Sold?
This product was distributed to 2 states: NJ, TN
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report