Akorn, Inc.

FDA recalling firm · 65 enforcement events · 192 product records · 2014–2023 · IL

Akorn, Inc. has 65 FDA enforcement events on this register (192 product records) between 2014 and 2023: 65 drug; the busiest year was 2019 with 13.

0% of its events are Class I; the most common class is Class II (37). 6 events are listed as ongoing; the recalling firm's address is in IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
26 Apr 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	Drug	Class II	86	Ongoing
30 Jan 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	Drug	Class III	1	Ongoing
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, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35	Drug	Class II	27	Ongoing
21 Sep 2022	Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30	Drug	Class II	2	Ongoing
31 Aug 2022	Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31	Drug	Class II	2	Terminated
8 Aug 2022	Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24	Drug	Class III	1	Ongoing
1 Aug 2022	PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24	Drug	Class II	1	Ongoing
13 Jun 2022	Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16	Drug	Class II	1	Terminated
10 Jun 2022	Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02	Drug	Class II	1	Terminated
15 Apr 2022	Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04	Drug	Class III	1	Terminated
5 Jan 2022	Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.	Drug	Class II	1	Terminated
3 Dec 2021	Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30	Drug	Class III	2	Terminated
4 Oct 2021	Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11	Drug	Class II	1	Terminated
8 Sep 2021	TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30	Drug	Class II	1	Terminated
13 Aug 2021	Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701	Drug	Class II	1	Terminated
2 Aug 2021	Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35	Drug	Class II	1	Terminated
8 Mar 2021	Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07	Drug	Class II	1	Terminated
28 Dec 2020	Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16	Drug	Class II	1	Terminated
3 Sep 2020	Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01	Drug	Class II	1	Terminated
5 Jun 2020	Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04	Drug	Class III	1	Terminated
25 Mar 2020	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02	Drug	Class III	1	Terminated
21 Feb 2020	Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35	Drug	Class III	3	Terminated
26 Dec 2019	Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12	Drug	Class III	1	Terminated
16 Dec 2019	Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.	Drug	Class II	1	Terminated
15 Nov 2019	MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.	Drug	Class II	1	Terminated
20 Sep 2019	Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.	Drug	Class II	1	Terminated
17 Sep 2019	Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30	Drug	Class II	1	Terminated
6 Aug 2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.	Drug	Class III	3	Terminated
7 Jun 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	Drug	Class III	1	Terminated
23 Apr 2019	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25	Drug	Class III	1	Terminated
28 Mar 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	Drug	Class III	1	Terminated
12 Mar 2019	Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10	Drug	Class II	1	Terminated
22 Feb 2019	Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.	Drug	Class II	1	Terminated
4 Feb 2019	Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.	Drug	Class II	1	Terminated
25 Jan 2019	Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.	Drug	Class III	1	Terminated
20 Dec 2018	COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10	Drug	Class III	1	Terminated
29 Oct 2018	Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60	Drug	Class III	1	Terminated
8 Oct 2018	Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10	Drug	Class II	1	Terminated
24 Aug 2018	Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01	Drug	Class II	1	Terminated
8 Aug 2018	Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10	Drug	Class III	1	Terminated
1 Aug 2018	Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30	Drug	Class II	1	Terminated
22 Jun 2018	Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.	Drug	Class II	1	Terminated
29 Mar 2018	Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.	Drug	Class III	3	Terminated
9 Mar 2018	Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.	Drug	Class III	1	Terminated
21 Feb 2018	Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05	Drug	Class III	1	Terminated
15 Dec 2017	Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47	Drug	Class III	1	Terminated
12 Jul 2017	Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.	Drug	Class III	3	Terminated
20 Apr 2017	IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02	Drug	Class III	1	Terminated
17 Mar 2017	LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12	Drug	Class II	1	Terminated
13 Mar 2017	Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16	Drug	Class II	1	Terminated
14 Nov 2016	Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY	Drug	Class II	1	Terminated
21 Oct 2016	Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.	Drug	Class II	1	Terminated
27 Jul 2016	Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.	Drug	Class III	1	Terminated
17 May 2016	Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12	Drug	Class II	1	Terminated
7 Apr 2016	Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% /…	Drug	Class II	1	Terminated
23 Mar 2016	ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O	Drug	Class II	3	Terminated
21 Aug 2015	Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10	Drug	Class III	1	Terminated
20 Aug 2015	RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.	Drug	Class III	1	Terminated
20 Apr 2015	IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by:…	Drug	Class III	1	Terminated
7 Apr 2015	Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16	Drug	Class II	2	Terminated
17 Mar 2015	SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701	Drug	Class II	3	Terminated
27 Feb 2015	Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.	Drug	Class II	1	Terminated
28 Jan 2015	Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .	Drug	Class II	1	Terminated
9 Dec 2014	Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).	Drug	Class III	1	Terminated
5 Aug 2014	Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42	Drug	Class III	1	Terminated

By type and class

Drug65

Class II37

Class III28

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Akorn, Inc. by year initiated.

Questions and answers

How many FDA recalls has Akorn, Inc. had?

65 enforcement events (192 product records) on this register, 2014–2023: 65 drug.

Are any Akorn, Inc. recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Akorn, Inc. recalls?

37 Class II, 28 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.