Drug recall: Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL…

Class II FDA enforcement event 91788. Recall start date: 26 Apr 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Akorn, Inc. started this drug recall on 26 Apr 2023. The firm address in the FDA record is in Gurnee, IL. FDA put the recall in Class II. FDA event 91788 has 86 product records. The first FDA enforcement report date is 7 Jun 2023. The record gives the status Ongoing.

FDA enforcement report The 86 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA and Puerto Rico

Recalling firm

Akorn, Inc., Gurnee, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

86 product records in the event.

FDA event 91788: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0779-2023	Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0780-2023	Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0781-2023	Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0782-2023	Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0783-2023	Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0784-2023	Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0785-2023	Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0786-2023	Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0787-2023	Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0788-2023	AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0789-2023	Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0790-2023	Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0791-2023	Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain…	N/A	Class II	Ongoing	7 Jun 2023
D-0792-2023	Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0793-2023	Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0794-2023	Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0795-2023	Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0796-2023	Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0797-2023	Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0798-2023	DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0799-2023	Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0800-2023	Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0801-2023	DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0802-2023	Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0803-2023	Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0804-2023	Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0805-2023	Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0806-2023	Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0807-2023	Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0808-2023	Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0809-2023	HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0810-2023	Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0811-2023	Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0812-2023	IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0813-2023	Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0814-2023	Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0815-2023	Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0816-2023	Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0817-2023	Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0818-2023	Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0819-2023	Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0820-2023	Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0821-2023	Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0822-2023	Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0823-2023	Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0824-2023	Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0825-2023	Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0826-2023	Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0827-2023	Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0828-2023	Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0829-2023	Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0830-2023	Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0831-2023	Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0832-2023	Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0833-2023	Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0834-2023	Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0835-2023	Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0836-2023	Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0837-2023	Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023
D-0838-2023	Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs	N/A	Class II	Ongoing	7 Jun 2023

The table shows 60 of 86 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class II: 59%
Product records in this event: 86Median of the firm: 1
Events of the firm on the register: 65

Other events of the firm

Other FDA enforcement events of Akorn, Inc.
Initiated	Product (first record)	Type	Class	Records
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
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

Akorn, Inc.: all 65 events

Official channels

FDA enforcement report D-0779-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 91788. https://recallregister.com/fda/ii/91788/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA and Puerto Rico
What quantity of product is in FDA event 91788?: The event has 86 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2023 have the same class?: 59% of the 281 drug events that started in 2023 are in Class II.