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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

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 mL bottles, Rx Only, Distributed by: Akorn, Inc., 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

Levofloxacin Ophthalmic Solution, 0.5%, 5 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

Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx 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

Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: 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

Lidocaine HCl Jelly USP, 2%, 5mL tubes, 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

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL 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

Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, 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

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL 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

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 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

Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, 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

Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 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

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, 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

Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, 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

Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured 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

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 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

Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 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

Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL 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

Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 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

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, 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

Promethazine HCl Oral Solution, USP, 6.25 mg/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

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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