Drug recall: Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, R

FDA enforcement event 83073 · Class III · initiated 7 Jun 2019 · status Terminated · terminated 28 Jul 2022

DrugVoluntary: Firm initiated1 product recordLake Forest, IL

Akorn Inc (Lake Forest, IL) initiated this drug recall on 7 Jun 2019; FDA lists 1 product record under event 83073, 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. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 28 Jul 2022. Initiation: voluntary: firm initiated. Akorn Inc has 65 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

Akorn Inc, Lake Forest, IL.

Reason for recall

"Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly."

Distribution

"Nationwide USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1392-2019	Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13	16,216 cartons	Class III	Terminated	26 Jun 2019

Context

22%of 2019 drug events are Class III362 events that year

1product record in this eventfirm median: 1

65events on this register for the firm

Other enforcement events for Akorn Inc

Initiated	Product (first record)	Type	Class	Records
26 Apr 2023	Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bo	Drug	Class II	86
30 Jan 2023	Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib	Drug	Class III	1
13 Oct 2022	AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile	Drug	Class II	27
21 Sep 2022	Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031	Drug	Class II	2
31 Aug 2022	Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045,	Drug	Class II	2
8 Aug 2022	Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn,	Drug	Class III	1
1 Aug 2022	PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1170	Drug	Class II	1
13 Jun 2022	Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by:	Drug	Class II	1
10 Jun 2022	Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHA	Drug	Class II	1
15 Apr 2022	Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pha	Drug	Class III	1

All 65 events for Akorn Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly."

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 28 Jul 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.