Home / 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. Source coverage and dates.

Records and reported status

Apr 26, 2023FDA drug enforcement

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 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

Diuril (chlorothiazide sodium) Injection, 500mg/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

DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, 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

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, 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

Ferrous Sulfate Iron Supplement Drops, packaged in 50 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

Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. 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

Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 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

Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use 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

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bot...

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

Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, 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

HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, 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

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 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

Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lak...

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

IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, 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

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)10 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, ...

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

Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee,...

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

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, 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

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, 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

Levocarnitine Oral Solution, USP, 118 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 Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600...

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.

Keep checking