Severity
Low
FDA Drug recall · Reported July 1, 2020
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
American Health Packaging recalled Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), … - a low-severity action.
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), … was recalled by American Health Packaging in July 1, 2020. Reason: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide…. Check the official notice for the remedy. Verify recall #D-1372-2020 with the FDA Drug before acting.
The recall
American Health Packaging issued this low-severity FDA Drug recall-Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide….
Sourced from official FDA Drug enforcement records. Verify recall #D-1372-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1372-2020) was formally reported on July 1, 2020, with the manufacturer initiating the action on June 10, 2020. It is classified under Low severity (Class III), with a current status of Terminated. American Health Packaging is listed as the recalling firm, operating out of Columbus, OH. Federal records list the affected scope as 265 cartons.
The documented reason for this recall is: Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. Distribution data in the federal record shows the product reached: Nationwide USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
265 cartons
Related Recalls
6
5 from same agency
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
Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1372-2020 |
| Date reported | July 1, 2020 |
| Date initiated | June 10, 2020 |
| Recalling firm | American Health Packaging |
| Firm location | Columbus, OH |
| Affected scope | 265 cartons |
| Distribution | Nationwide USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Safecor Health, LLC · 2026-05-27
IntegraDose Compounding Services LLC · 2026-05-27
Lupin Pharmaceuticals Inc. · 2026-05-27
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 1, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.