CLASS III Drug recall · Reported 9 Sep 2015 · FDA Enforcement Report
Allopurinol Tablets, USP, 300 mg recalled by Qualitest Pharmaceuticals
Qualitest Pharmaceuticals is recalling Allopurinol Tablets, USP, 300 mg, distributed nationwide in the US. The recall was initiated on 20 Jul 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
- D-1405-2015
- FDA event ID
- 71776
- Recalling firm
- Qualitest Pharmaceuticals, Huntsville, AL
- Brand
- Allopurinol
- Manufacturer
- Par Health USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jul 2015
- FDA classified
- 1 Sep 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 20 Jul 2015 | Recall initiated by company | |
| 1 Sep 2015 | Classified by FDA | +43 days |
| 9 Sep 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/Capsule Specifications; report of oversized and discolored tablets
Product as listed by the FDA
ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28
Where it was distributed
Nationwide and PR
Questions about this recall
Is Allopurinol Tablets, USP, 300 mg recalled?
Yes. Qualitest Pharmaceuticals recalled Allopurinol Tablets, USP, 300 mg on 20 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1405-2015.
Why was it recalled?
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Which lots are affected?
CP0761501, Exp. 12/16
Where was it sold?
Nationwide and PR
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 | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Disulfiram tablets, USP, 500 mg recalled by Qualitest Pharmaceuticals | Qualitest Pharmaceuticals | Potency & Assay | 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 Allopurinol recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Allopurinol Tablets, USP 300mg recalled by Dr. Reddy's LaboratoriesAllopurinol | Dr. Reddy's Laboratories | Other | IL, MS, OH |
| Drug | CLASS II | Allopurinol Tablets recalled by Cardinal HealthcareAllopurinol | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Allopurinol Tablets 100mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Foreign Material | IN |
| Drug | CLASS II | Allopurinol Tablets USP, 100 mg recalled by Accord HealthcareAllopurinol | Accord Healthcare | Foreign Material | Nationwide |
| Drug | CLASS II | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial recalledAloprim | Mylan Institutional | Potency & Assay | Nationwide |