--- title: "Akorn, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Akorn, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/akorn-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Akorn, Inc. recall records **118** reported ongoing 127 records in this archive. Latest source date Apr 26, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 26, 2023 FDA drug enforcement ### [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, Distribute...](https://isitonrecall.com/recall/fda-drug-d-0779-2023-atropine-sulfate-ophthalmic-solution-usp-1-for-topical-application-to-the-eye-packaged-in-a-2-ml-bot/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0779-2023%22) Apr 26, 2023 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0780-2023-acetaminophen-codeine-phosphate-oral-solution-120mg-12mg-5ml-packaged-in-a-473ml-bottles-and-b-40-ud/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0780-2023%22) Apr 26, 2023 FDA drug enforcement ### [Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0781-2023-acetic-acid-otic-solution-15-ml-per-bottle-rx-only-distributed-by-akorn-operating-company-llc-gurnee/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0781-2023%22) Apr 26, 2023 FDA drug enforcement ### [Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0782-2023-acyclovir-oral-suspension-200mg-5ml-rx-only-distributed-by-akorn-operating-company-llc-gurnee-il-600/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurne...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0782-2023%22) Apr 26, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0783-2023-albuterol-sulfate-syrup-2mg-base-16-fl-oz-473-ml-per-bottle-rx-only-distributed-by-akorn-operating-c/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0783-2023%22) Apr 26, 2023 FDA drug enforcement ### [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, ...](https://isitonrecall.com/recall/fda-drug-d-0784-2023-apraclonidine-ophthalmic-solution-0-5-packaged-in-a-5ml-and-b-10-ml-bottles-rx-only-sterile-for-topi/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0784-2023%22) Apr 26, 2023 FDA drug enforcement ### [Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0785-2023-artificial-tears-solution-polyvinyl-alcohol-1-4-for-ophthalmic-use-only-distributed-by-akorn-operati/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0785-2023%22) Apr 26, 2023 FDA drug enforcement ### [Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0786-2023-artificial-tears-ointment-sterile-for-ophthalmic-use-only-3-5-gram-tubes-distributed-by-akorn-operat/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akor...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0786-2023%22) Apr 26, 2023 FDA drug enforcement ### [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](https://isitonrecall.com/recall/fda-drug-d-0787-2023-azelastine-hydrochloride-nasal-spray-0-15-105-5-mcg-per-spray-rx-only-for-intranasal-use-only-manufa/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Onl...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0787-2023%22) Apr 26, 2023 FDA drug enforcement ### [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. ...](https://isitonrecall.com/recall/fda-drug-d-0788-2023-ak-poly-bac-bacitracin-zinc-and-polymyxin-b-sulfate-ophthalmic-ointment-3-5g-sterile-rx-only-for-oph/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0788-2023%22) Apr 26, 2023 FDA drug enforcement ### [Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0789-2023-calcipotriene-topical-solution-0-005-scalp-solution-60-ml-bottles-rx-only-distributed-by-akorn-opera/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0789-2023%22) Apr 26, 2023 FDA drug enforcement ### [Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0790-2023-calcitriol-injection-1-mcg-ml-1-ml-ampules-rx-only-distributed-by-akorn-operating-company-llc-gurnee/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0790-2023%22) Apr 26, 2023 FDA drug enforcement ### [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 d...](https://isitonrecall.com/recall/fda-drug-d-0791-2023-cetrorelix-acetate-for-injection-0-25-mg-one-carton-contains-one-packaged-tray-which-contains-1-vial/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0791-2023%22) Apr 26, 2023 FDA drug enforcement ### [Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0792-2023-ciclopirox-topical-solution-8-nail-lacquer-6-6-ml-bottles-rx-only-distributed-by-akorn-operating-com/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Ope...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0792-2023%22) Apr 26, 2023 FDA drug enforcement ### [Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0793-2023-cimetidine-hcl-oral-solution-300mg-5ml-237-ml-bottles-rx-only-distributed-by-akorn-operating-company/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0793-2023%22) Apr 26, 2023 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0794-2023-clobetasol-propionate-cream-usp-0-05-packaged-in-a-15g-tubes-b-30g-tubes-and-c-60g-tubes-rx-only-dis/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0794-2023%22) Apr 26, 2023 FDA drug enforcement ### [Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0795-2023-clobetasol-propionate-ointment-usp-0-05-15-g-tubes-rx-only-distributed-by-akorn-operating-company-ll/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0795-2023%22) Apr 26, 2023 FDA drug enforcement ### [Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0796-2023-clobetasol-propionate-shampoo-0-05-4oz-118-ml-bottles-rx-only-distributed-by-akorn-operating-company/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operat...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0796-2023%22) Apr 26, 2023 FDA drug enforcement ### [Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0797-2023-cromolyn-sodium-ophthalmic-solution-usp-4-10-ml-bottles-rx-only-manufactured-by-akorn-inc-lake-fores/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc....](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0797-2023%22) Apr 26, 2023 FDA drug enforcement ### [DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs](https://isitonrecall.com/recall/fda-drug-d-0798-2023-detomised-detomidine-hydrochloride-packaged-in-a-5ml-and-b-20ml-vials-rx-only-distributed-by-akorn-o/) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class II Reported ongoing Distribution: Nationwide in the USA and Puerto Rico [Official source for DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0798-2023%22) ## Reasons in these listed records - CGMP Deviations: Firm went out of business and could no longer continue stability studies. These examples come from this result page and are not a ranking of every recall reason. ## Checking Akorn, Inc. ### Is there a recall on akorn, inc. right now? This archive contains 127 records, including 118 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Akorn, Inc.](https://isitonrecall.com/check/?q=Akorn%2C%20Inc.) 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