Food, drugs, devices › American Health Packaging

Drug recall: Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, C

FDA enforcement event 99674 · Class III · initiated 19 Aug 2026 · status Ongoing

DrugVoluntary: Firm initiated1 product recordColumbus, OH

American Health Packaging (Columbus, OH) initiated this drug recall on 19 Aug 2026; FDA lists 1 product record under event 99674, 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. 15% of the 234 drug enforcement events initiated in 2026 carry the same class.

Status: Ongoing. 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: Label Mix-up"

Distribution

"US Nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0840-2026	Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).	10,953 cartons.	Class III	Ongoing	9 Sep 2026

Context

15%of 2026 drug events are Class III234 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
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
10 Jun 2020	Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Americ	Drug	Class III	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: Label Mix-up"

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: "US Nationwide."

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.