The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D1151-2015·Announced 2015-07-08

Qualitest Recalls Disulfiram Tablets Due to Dissolution Failure

Qualitest Pharmaceuticals is recalling 2,016 bottles of Disulfiram tablets because one lot failed routine stability testing for dissolution specifications.

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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety threat like contamination or mislabeling of a critical allergen.

Plain-English summary

Qualitest Pharmaceuticals is voluntarily recalling 2,016 bottles of Disulfiram tablets, USP, 500 mg, 100-count bottles. The affected product is prescription-only and was distributed nationwide. The specific lot numbers involved are T142A14A, T143A14A, and T144A14A, all with an expiration date of 01/16.

The recall was initiated after routine stability testing at the 12-month time point revealed that one product lot was out of specification for dissolution. This means the tablets may not dissolve at the required rate, potentially affecting the medication's performance.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be discontinued and returned to the supplier or disposed of according to local regulations. No adverse health effects have been reported in connection with this recall.

The recalled product

Product
Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
2,016

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 (4)

  • Lot #: T142A14A
  • T143A14A
  • T144A14A
  • Exp 01/16

Distribution

Distributed nationwide across the United States.

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