Labeler · US market

Akorn

Akorn is a US drug labeler with US FDA registrations covering 3 drug concepts (3 currently active) across 2 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes50383 · 61748

Active drugs3

Registrations3 active / 3

Packages2

Sole supplier of2 drugs

Portfolio3 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Trihexyphenidyl Hydrochloride syrup	rx	1	1	SUPPLYING
Famotidine powder, for solution	rx	1	1	SUPPLYING
Dorzolamide Hydrochloride And Timolol Maleate solution/ drops	rx	1	0	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes50383, 61748
Filing names1
Drugs (active)3
Drugs (all time)3
US registrations3
Packages2

Recent events

Shortages, recalls, and registration changes across all filing names.

Apr 26, 2023
RECALLRecall (Class II): Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 1170…
Apr 26, 2023
RECALLRecall (Class II): Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 6…
Apr 26, 2023
RECALLRecall (Class II): Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Apr 26, 2023
RECALLRecall (Class II): DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Comp…
Apr 26, 2023
RECALLRecall (Class II): Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating…
Apr 26, 2023
RECALLRecall (Class II): Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL …
Apr 26, 2023
RECALLRecall (Class II): Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 6003…
Apr 26, 2023
RECALLRecall (Class II): Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalm…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.