Recall archive
54 recalls · page 1 of 3
Reported Jun 7, 2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product details — CGMP Deviations: Firm went out of business and could no longer continue stability studies.
85 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 15, 2023
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
FDA (openFDA drug enforcement)
Reported Jan 25, 2023
AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product details — CGMP Deviations:
26 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 5, 2022
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 14, 2022
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 7, 2022
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
FDA (openFDA drug enforcement)
Reported Jul 6, 2022
Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported May 11, 2022
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Failed viscosity specification - product was below specificcation
FDA (openFDA drug enforcement)
Reported Mar 30, 2022
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility
FDA (openFDA drug enforcement)
Reported Jan 19, 2022
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Labeling: Missing Label
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 13, 2021
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product details — Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
FDA (openFDA drug enforcement)
Reported Sep 22, 2021
Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
FDA (openFDA drug enforcement)
Reported Sep 8, 2021
Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation…
FDA (openFDA drug enforcement)
Reported Mar 24, 2021
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
FDA (openFDA drug enforcement)
Reported Jan 20, 2021
Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — Defective container: Customer complaints for oral solution leaking from bottles.
FDA (openFDA drug enforcement)
Reported Oct 7, 2020
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand — CGMP Deviations
FDA (openFDA drug enforcement)
Reported Jul 22, 2020
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
FDA (openFDA drug enforcement)
Reported Jun 17, 2020
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand — Discoloration: Out of Specification (OOS) result for APHA Color Test.
FDA (openFDA drug enforcement)
Reported Apr 8, 2020
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn Inc.
Matched: Brand · Product details — Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
FDA (openFDA drug enforcement)
Reported Mar 4, 2020
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product · Product details — Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 8, 2020
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product details — Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of…
FDA (openFDA drug enforcement)
Reported Oct 9, 2019
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
FDA (openFDA drug enforcement)
Reported Oct 2, 2019
Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Akorn, Inc.
Matched: Brand · Product · Product details — cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product.…
FDA (openFDA drug enforcement)
Reported Sep 4, 2019
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Akorn, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
2 more products in this recall
FDA (openFDA drug enforcement)
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