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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

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...

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

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 ...

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

Acetic Acid Otic Solution, 15 mL per bottle, 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

Acyclovir Oral Suspension, 200mg/5mL, 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

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

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

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, ...

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

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use 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

Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, 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

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

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

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. ...

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

Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 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

Calcitriol Injection 1 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

Apr 26, 2023FDA 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...

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

Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 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

Cimetidine HCl Oral Solution 300mg/5mL, 237 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

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 ...

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

Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, 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

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 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

Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL 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

DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, 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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