Amlodipine Tablets (Lupin) – Potency Failure (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lot #: A102887, Exp. 6/2023
Products Sold
Lot #: A102887, Exp. 6/2023
Lupin Pharmaceuticals Inc. is recalling Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmac due to Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026