Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 6, 2022DrugsFDA
Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by:
Hazard: Defective container: defect prevents product from dispensing as intended.
July 6, 2022DrugsFDA
Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHA
Hazard: Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
May 11, 2022DrugsFDA
Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pha
Hazard: Failed viscosity specification - product was below specificcation
March 30, 2022DrugsFDA
Akorn, Inc. recalls TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn C
Hazard: Lack of Assurance of Sterility
January 19, 2022DrugsFDA
Akorn, Inc. recalls Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warni
Hazard: Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
January 19, 2022DrugsFDA
Akorn, Inc. recalls Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pha
Hazard: Labeling: Missing Label
January 19, 2022DrugsFDA
Akorn, Inc. recalls Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityvill
Hazard: Labeling: Missing Label
October 13, 2021DrugsFDA
Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured
Hazard: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
September 22, 2021DrugsFDA
Akorn, Inc. recalls Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottl
Hazard: Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
September 8, 2021DrugsFDA
Akorn, Inc. recalls Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, In
Hazard: Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
March 24, 2021DrugsFDA
Akorn, Inc. recalls Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only,
Hazard: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
January 20, 2021DrugsFDA
Akorn, Inc. recalls Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 1
Hazard: Defective container: Customer complaints for oral solution leaking from bottles.
October 7, 2020DrugsFDA
Akorn, Inc. recalls Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsoc
Hazard: CGMP Deviations
July 22, 2020DrugsFDA
Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:
Hazard: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
June 17, 2020DrugsFDA
Akorn, Inc. recalls Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville,
Hazard: Discoloration: Out of Specification (OOS) result for APHA Color Test.
April 8, 2020DrugsFDA
Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by:
Hazard: Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
March 4, 2020DrugsFDA
Akorn, Inc. recalls CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Wo
Hazard: 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 the materials of construction for the tube.
March 4, 2020DrugsFDA
Akorn, Inc. recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd.,
Hazard: 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 the materials of construction for the tube.
March 4, 2020DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 174
Hazard: 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 the materials of construction for the tube.
February 19, 2020DrugsFDA
Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityvill
Hazard: Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
January 8, 2020DrugsFDA
Akorn, Inc. recalls MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only,
Hazard: Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
October 9, 2019DrugsFDA
Akorn, Inc. recalls Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL
Hazard: Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
October 2, 2019DrugsFDA
Akorn, Inc. recalls Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 6004
Hazard: cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 10
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactur
Hazard: Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
September 4, 2019DrugsFDA
Akorn, Inc. recalls Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactur
Hazard: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
June 26, 2019DrugsFDA
Akorn Inc recalls Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, R
Hazard: Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
May 1, 2019DrugsFDA
Akorn Inc recalls Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by:
Hazard: Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
April 10, 2019DrugsFDA
Akorn, Inc. recalls Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville
Hazard: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
March 27, 2019DrugsFDA
Akorn Inc recalls Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityv
Hazard: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.