CLASS II Drug recall · Reported 11 Mar 2015 · FDA Enforcement Report

Amlodipine Besylate Tablets USP, 10 mg* bottles recalled

Qualitest Pharmaceuticals is recalling Amlodipine Besylate Tablets USP, 10 mg* bottles (, distributed nationwide in the US. The recall was initiated on 13 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot T018H14A, Exp 08/16

Quantity recalled2808 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0397-2015
FDA event ID: 70503
Recalling firm: Qualitest Pharmaceuticals, Huntsville, AL
Classification: Class II
Status: Terminated
Recall initiated: 13 Feb 2015
FDA classified: 3 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Blood Pressure Medication

Timeline

13 Feb 2015	Recall initiated by company
3 Mar 2015	Classified by FDA	+18 days
11 Mar 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot T018H14A, Exp 08/16

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide