Qualitest Pharmaceuticals Amlodipine Besylate Tablets Recall

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot T018H14A, Exp 08/16

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0397-2015
Classification: Class II
Status: Terminated
Recall initiated: Feb 13, 2015
FDA report date: Mar 11, 2015
Quantity: 2808 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Qualitest Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0397-2015, exactly as published.

Show all FDA fields

City: Huntsville
State: AL
Status: Terminated
Country: United States
Event ID: 70503
Address: 120 Vintage Dr NE
Code information: Lot T018H14A, Exp 08/16
Postal code: 35811-8216
Report date: Mar 11, 2015
Product type: Drugs
Recall number: D-0397-2015
Classification: Class II
Recalling firm: Qualitest Pharmaceuticals
Product quantity: 2808 bottles
Termination date: Jan 27, 2016
Reason for recall: Failed tablet specifications: One lot was found to contain oversized tablets.
Voluntary / mandated: Voluntary: Firm initiated
Product description: AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Distribution pattern: Nationwide
Recall initiation date: Feb 13, 2015
Initial firm notification: Letter
Center classification date: Mar 3, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0397-2015, published Mar 11, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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