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.
November 25, 2015DrugsFDA
Akorn, Inc. recalls Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, R
Hazard: Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
November 25, 2015DrugsFDA
Akorn, Inc. recalls RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Hazard: Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
September 23, 2015DrugsFDA
Akorn, Inc. recalls IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count I
Hazard: Subpotent Drug: Low out-of-specification potency result of the drug product.
June 17, 2015DrugsFDA
Akorn, Inc. recalls Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Ph
Hazard: Failed Impurities/Degradation Specifications
June 17, 2015DrugsFDA
Akorn, Inc. recalls Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech,
Hazard: Failed Impurities/Degradation Specifications
May 20, 2015DrugsFDA
Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50
Hazard: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
May 20, 2015DrugsFDA
Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (N
Hazard: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
May 20, 2015DrugsFDA
Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (
Hazard: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
March 11, 2015DrugsFDA
Akorn, Inc. recalls Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that prov
Hazard: Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
February 18, 2015DrugsFDA
Akorn, Inc. recalls Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPhar
Hazard: Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
January 14, 2015DrugsFDA
Akorn, Inc. recalls Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Hazard: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
October 1, 2014DrugsFDA
Akorn, Inc. recalls Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, indiv
Hazard: Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point