CLASS III Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report
Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals
Qualitest Pharmaceuticals is recalling Disulfiram tablets, USP, 500 mg, distributed nationwide in the US. The recall was initiated on 18 Jun 2015 and the FDA has classified it as Class III.
Check your package
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
- D1151-2015
- FDA event ID
- 71563
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jun 2015
- FDA classified
- 30 Jun 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Jun 2015 | Recall initiated by company | |
| 30 Jun 2015 | Classified by FDA | +12 days |
| 8 Jul 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 Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Disulfiram tablets, USP, 500 mg recalled?
Yes. Qualitest Pharmaceuticals recalled Disulfiram tablets, USP, 500 mg on 18 Jun 2015. The recall is Class III and its status is Terminated. Recall number D1151-2015.
Why was it recalled?
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Which lots are affected?
Lot #: T142A14A, T143A14A, T144A14A, Exp 01/16
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Qualitest Pharmaceuticals
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Promethazine VC With Codeine Syrup, Each contains recalled | Qualitest Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine DM Syrup (Promethazine Hydrochloride recalled | Qualitest Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Amlodipine Besylate Tablets USP, 10 mg* bottles recalled | Qualitest Pharmaceuticals | Other | Nationwide |
Other Disulfiram recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Disulfiram Tablet, 250 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS III | Disulfiram Tablets USP 250 mg recalled by Teva Pharmaceuticals USA | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |