Records and reported status
Apr 26, 2023 FDA drug enforcement
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 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL v... Apr 26, 2023 FDA drug enforcement
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 Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: A... Apr 26, 2023 FDA drug enforcement
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 Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distribut... Apr 26, 2023 FDA drug enforcement
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 Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distribut... Apr 26, 2023 FDA drug enforcement
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 Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manu... Apr 26, 2023 FDA drug enforcement
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 Tropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operatin... Jan 30, 2023 FDA drug enforcement
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class III 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, 2 mL bottle, St... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.)... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Man... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per b... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx ... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manuf... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, In... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactu... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per cart... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Pro... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL dropper bottle, NDC 17478-... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., La... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box N... Oct 13, 2022 FDA drug enforcement
CGMP Deviations:
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only, Manufactured by: A...
Reasons in these listed records CGMP Deviations: Firm went out of business and could no longer continue stability studies. Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint. CGMP Deviations: 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.