Food, drugs, devices › American Health Packaging

Drug recall: Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Americ

FDA enforcement event 85842 · Class III · initiated 10 Jun 2020 · status Terminated · terminated 3 Aug 2022

DrugVoluntary: Firm initiated1 product recordColumbus, OH

American Health Packaging (Columbus, OH) initiated this drug recall on 10 Jun 2020; FDA lists 1 product record under event 85842, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 3 Aug 2022. Initiation: voluntary: firm initiated. American Health Packaging has 42 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

American Health Packaging, Columbus, OH.

Reason for recall

"Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label."

Distribution

"Nationwide USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1372-2020	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	265 cartons	Class III	Terminated	1 Jul 2020

Context

21%of 2020 drug events are Class III342 events that year

1product record in this eventfirm median: 1

42events on this register for the firm

Other enforcement events for American Health Packaging

Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, C	Drug	Class III	1
3 May 2022	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10	Drug	Class III	1
12 Apr 2022	Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Ma	Drug	Class III	1
22 Feb 2022	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins	Drug	Class II	1
20 Dec 2021	Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories	Drug	Class II	1
17 Sep 2021	GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx o	Drug	Class II	1
15 Sep 2021	Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by:	Drug	Class II	1
12 May 2021	Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Heal	Drug	Class III	1
7 Jan 2021	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx onl	Drug	Class II	1
19 May 2020	Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packa	Drug	Class II	1

All 42 events for American Health Packaging

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide USA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.