Amlodipine Besylate 10 mg Tablets Recalled for Failing Potency Tests
Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recalls are typically rated 1 or 2. This recall involves a potency specification failure with no reported illnesses or injuries. While subpotency could reduce therapeutic efficacy in a cardiovascular medication, the absence of reported harm and the Class III classification support a moderate rather than low severity.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling approximately 3,096 bottles of Amlodipine Besylate Tablets, USP 10 mg due to subpotency. During a 21-month long-term stability study, testing showed the tablets contained less active ingredient than specified, resulting in an out-of-specification assay result.
Amlodipine Besylate is a prescription medication used to treat high blood pressure and chest pain. When tablets are subpotent, they may not provide the intended therapeutic effect. The affected product has Lot Number A102887 with an expiration date of 6/2023.
The recalled product was distributed directly to three distributors in Tennessee and New Jersey. Product may have been further distributed throughout the United States. Patients currently taking this medication should contact their pharmacist or healthcare provider immediately to discuss their medication and determine if they have received any of the recalled product.
Consumers or healthcare providers who have the recalled product should stop using it and return it to their pharmacy for proper disposal or replacement with product that meets specification.
The recalled product
- Product
- AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Oral
- Affected units
- 3,096
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: A102887
- Exp. 6/2023
UPCs (1)
- 0368180233022
Distribution
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Similar recalls
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FDA (Drugs) · 2018-10-17
- ModerateLupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations
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