The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0397-2015·Announced 2015-03-11

Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size

Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Qualitest Pharmaceuticals is voluntarily recalling 2,808 bottles of Amlodipine Besylate Tablets USP, 10 mg, 1000 count bottles (NDC 0603-2110-32). The recall affects Lot T018H14A, which has an expiration date of 08/16. The product was distributed nationwide.

The recall was initiated because one lot was found to contain oversized tablets, which failed to meet tablet specifications. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.

The recalled product

Product
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
2,808

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 T018H14A
  • Exp 08/16

Distribution

Distributed nationwide across the United States.

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