Drug recall: Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville

FDA enforcement event 82510 · Class III · initiated 28 Mar 2019 · status Terminated · terminated 22 Apr 2020

DrugVoluntary: Firm initiated1 product recordLake Forest, IL

FDA enforcement event 82510 is a drug recall by Akorn, Inc. of Lake Forest, IL, initiated 28 Mar 2019 and classified Class III, with 1 product record.

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 22 Apr 2020. 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

"Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing."

Distribution

"AR and MS"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1080-2019	Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16	2,796 bottles	Class III	Terminated	10 Apr 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: "Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing."

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: "AR and MS"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Apr 2020. "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.