Drug recall: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distrib

FDA enforcement event 91580 · Class III · initiated 30 Jan 2023 · status Ongoing

DrugVoluntary: Firm initiated1 product recordGurnee, IL

Akorn, Inc. (Gurnee, IL) initiated this drug recall on 30 Jan 2023; FDA lists 1 product record under event 91580, 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. 26% of the 281 drug enforcement events initiated in 2023 carry the same class.

Status: Ongoing. 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., Gurnee, IL.

Reason for recall

"Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint."

Distribution

"Nationwide in the USA and Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0265-2023	Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02	45,117 Bottles	Class III	Ongoing	15 Feb 2023

Context

26%of 2023 drug events are Class III281 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
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
5 Jan 2022	Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warni	Drug	Class II	1

All 65 events for Akorn, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint."

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 in the USA and Puerto Rico"

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.