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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. Source coverage and dates.

Records and reported status

Apr 26, 2023FDA drug enforcement

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Ak...

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ...

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Fo...

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

Apr 26, 2023FDA drug enforcement

Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

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

Class IIReported ongoing

Distribution: Nationwide in the USA and Puerto Rico

Official source

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 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 and the agency's current notices.

Where can I find older records?

Use monthly 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.

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