CLASS III Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Nabumetone Tablets, USP, 500 mg per carton x 10 blister cards) recalled
American Health Packaging is recalling Nabumetone Tablets, USP, 500 mg per carton x 10 blister cards), distributed nationwide in the US. The recall was initiated on 10 Jun 2020 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-1372-2020
- FDA event ID
- 85842
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Jun 2020
- FDA classified
- 1 Jul 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 10 Jun 2020 | Recall initiated by company | |
| 1 Jul 2020 | Classified by FDA | +21 days |
| 1 Jul 2020 | Published in enforcement report | +0 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: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Which lots are affected?
Lot #: 189551, Exp 04/30/2021
Where was it sold?
Nationwide USA
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.
More recalls from American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Nabumetone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nabumetone Tablets USP, 750 mg,Teva Pharmaceutical recalled | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Nabumetone, Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |