US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 13, 2015 (12 years ago)

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed tablet specifications: One lot was found to contain oversized tablets.

What was recalled

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Recalling firm
Qualitest Pharmaceuticals
NDC code
0603-2110-32
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0397-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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