Akorn recalls
14 official recalls and safety alerts involving Akorn since 2021-10, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Akorn or the relevant agency.
- 2023-06-07
USAkorn, Inc. recalls Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only,…
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-02-15
- US
Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn…
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
- 2023-01-25
- US
- 2022-10-05
- US
Akorn, Inc. recalls Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- 2022-09-14
- US
Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- 2022-09-07
- US
Akorn, Inc recalls Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake…
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
- 2022-08-24
- US
Akorn, Inc recalls PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Defective Container: Product has incomplete induction seals.
- 2022-07-06
- US
Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle, Rx only, Manufactured by: HI-TECH PHARMACAL…
Defective container: defect prevents product from dispensing as intended.
- US
Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC.,…
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
- 2022-05-11
- US
Akorn, Inc. recalls Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc.…
Failed viscosity specification - product was below specificcation
- 2022-03-30
- US
- 2022-01-19
- US
Akorn, Inc. recalls 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…
Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.
- US
- 2021-10-13
- US
Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc.,…
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.