Manufacturer

Akorn, Inc.

128 recalls in our database name Akorn, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 128

ModerateFDA (Drugs)·D-0146-2023·2023-01-25
Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues
Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.
Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0158-2023·2023-01-25
FDA Recalls Tobramycin Ophthalmic Solution for Manufacturing Compliance Issues
Akorn, Inc. is recalling 91,692 bottles of Tobramycin Ophthalmic Solution (0.3%) nationwide due to Current Good Manufacturing Practice deviations. The voluntary recall was initiated on October 13, 2022.
Product
Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC 13985-604-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0145-2023·2023-01-25
FDA recalls Akorn ophthalmic ointment for manufacturing process deviations
Akorn, Inc. is recalling 2,082 tubes of Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment nationwide due to manufacturing process deviations. The recall is voluntary and initiated by the manufacturer.
Product
Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0148-2023·2023-01-25
Ophthalmic solution recalled due to manufacturing quality control deviations
Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.
Product
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0140-2023·2023-01-25
FDA recalls GONAK ophthalmic drug solution for manufacturing deviations
Akorn voluntarily recalled 196,254 bottles of GONAK ophthalmic solution nationwide due to CGMP manufacturing practice deviations. This professional-use eye solution is employed in gonioscopic examinations.
Product
GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dropper bottle, For Professional Use in Goinoscopic Examinations, Mfd. by: Akorn, INc., Lake Forest, IL 60045. NDC: 17478-064-12
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0143-2023·2023-01-25
Lidocaine Hydrochloride Jelly Recalled for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 2,369,258 tubes of Lidocaine Hydrochloride Jelly due to manufacturing quality deviations. The product, distributed nationwide, is available in 5 mL and 30 mL prescription-only tubes.
Product
Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10 per box NDC 17478-711-31; (b) 30 mL tube NDC 17478-711-30; Rx only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0150-2023·2023-01-25
Antihistamine eye drops recalled due to manufacturing process deviations
Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0136-2023·2023-01-25
Ciprofloxacin ophthalmic solution recalled for manufacturing practice deviations
Akorn, Inc. is recalling 1,584 bottles of Ciprofloxacin Ophthalmic Solution nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall.
Product
Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0155-2023·2023-01-25
Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations
Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0142-2023·2023-01-25
Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues
Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.
Product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0138-2023·2023-01-25
Drug Recall: Erythromycin Ophthalmic Ointment Due to Manufacturing Deviations
Akorn, Inc. recalls 1.1 million tubes of Erythromycin Ophthalmic Ointment nationwide due to manufacturing deviations. The voluntary, Class II recall was initiated by the firm.
Product
ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0134-2023·2023-01-25
Akorn Artificial Tears Eye Drops Recalled for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 967,075 bottles of Artificial Tears Solution eye drops nationwide due to manufacturing process deviations identified during quality inspections.
Product
Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0137-2023·2023-01-25
FDA Recalls Cromolyn Sodium Eye Drops Nationwide for Manufacturing Defects
Akorn, Inc. is recalling 188,550 bottles of Cromolyn Sodium Ophthalmic Solution nationwide due to manufacturing quality control deviations.
Product
Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0152-2023·2023-01-25
FDA Recalls Akorn PAREMYD Eye Medication for Manufacturing Quality Deviations
Akorn, Inc. is voluntarily recalling 51,601 bottles of PAREMYD eye medication nationwide due to manufacturing process deviations. The firm initiated the recall in October 2022.
Product
PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1548-2022·2022-10-05
Akorn Rifampin Capsules Recalled for Impurity Specification Failure
Akorn is recalling Rifampin Capsules USP 300 mg (30-, 60-, and 100-count bottles) distributed nationwide because finished product exceeds the interim limit for 1-Methyl-4-Nitrosopiperazine impurity. The recall affects approximately 177,439 bottles.
Product
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1547-2022·2022-10-05
Rifampin Capsules Recalled for Exceeding Impurity Specification Limits
Akorn, Inc. is recalling 18,145 bottles of Rifampin Capsules, USP 150 mg due to impurity levels exceeding the FDA's 5 ppm interim specification limit for 1-Methyl-4-Nitrosopiperazine (MNP).
Product
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1496-2022·2022-09-14
Sodium Chloride Ophthalmic Ointment Recalled for Turbidity and Sterility Concerns
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.
Product
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1495-2022·2022-09-14
Lidocaine Hydrochloride Jelly Recalled Due to cGMP Deviations and Turbidity
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Product
Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1172-2022·2022-07-06
Fluticasone Propionate Nasal Spray Recalled Due to Defective Container
Akorn, Inc. is recalling 44,400 bottles of Fluticasone Propionate Nasal Spray nationwide due to a defective container that prevents proper dispensing. Patients should contact their healthcare provider or pharmacist.
Product
Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC 50383-700-16
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1170-2022·2022-07-06
Calcipotriene Scalp Solution Recalled Due to Defective Delivery System
Akorn, Inc. is recalling Calcipotriene Topical Solution 0.005% (Scalp Solution) nationwide due to a defective delivery system that could prevent the product from dispensing properly.
Product
Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0846-2022·2022-05-11
Lidocaine Oral Topical Solution Recalled Due to Failed Viscosity Specification
Akorn, Inc. is recalling 66,744 bottles of Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Lot #370978) nationwide because the product's viscosity was below the required specification.
Product
Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0717-2022·2022-03-30
Eye Lubricant Drops Recalled for Insufficient Sterility Assurance
Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.
Product
THERATEARS EXTRA — THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0460-2022·2022-01-19
Sufentanil Citrate Injection Recalled for Subpotency
Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.
Product
Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0368-2022·2022-01-19
Oxycodone Hydrochloride Oral Solution recalled for missing label
Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL distributed nationwide due to missing label.
Product
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0367-2022·2022-01-19
Morphine Sulfate Oral Solution 20 mg/mL recalled for missing label
Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.
Product
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
Category
Drug
Distribution
Distributed nationwide