CLASS III Drug recall · Reported 23 Mar 2016 · FDA Enforcement Report
Nabumetone Tablets USP, 750 mg,Teva Pharmaceutical recalled
Teva Pharmaceuticals USA is recalling Nabumetone Tablets USP, 750 mg,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, distributed nationwide in the US. The recall was initiated on 19 Nov 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-0773-2016
- FDA event ID
- 72999
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Nov 2015
- FDA classified
- 11 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 19 Nov 2015 | Recall initiated by company | |
| 11 Mar 2016 | Classified by FDA | +113 days |
| 23 Mar 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Product as listed by the FDA
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Which lots are affected?
Lot #: 05N533, Exp 11/16
Where was it sold?
Nationwide and Puerto Rico.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Nabumetone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nabumetone Tablets, USP, 500 mg per carton x 10 blister cards) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Nabumetone, Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |