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.
March 20, 2019DrugsFDA
Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL
Hazard: Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
February 27, 2019DrugsFDA
Akorn Inc recalls Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx o
Hazard: Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
February 27, 2019DrugsFDA
Akorn Inc recalls Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200
Hazard: Failed Stability Specification: out of specification results for Sodium Perborate
February 20, 2019DrugsFDA
Akorn Inc recalls COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx
Hazard: Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
February 6, 2019DrugsFDA
Akorn, Inc. recalls Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest
Hazard: Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.
December 5, 2018DrugsFDA
Akorn, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufact
Hazard: Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
September 12, 2018DrugsFDA
Akorn, Inc. recalls Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 3006
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
September 5, 2018DrugsFDA
Akorn, Inc. recalls Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn,
Hazard: Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
August 15, 2018DrugsFDA
Akorn, Inc. recalls Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville,
Hazard: Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
July 18, 2018DrugsFDA
Akorn, Inc. recalls Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 1747
Hazard: CGMP Deviations
April 4, 2018DrugsFDA
Akorn, Inc. recalls 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Glucon
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
April 4, 2018DrugsFDA
Akorn, Inc. recalls 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Glucon
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
April 4, 2018DrugsFDA
Akorn, Inc. recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups
Hazard: Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
March 28, 2018DrugsFDA
Akorn, Inc. recalls Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 3006
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
March 14, 2018DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Fores
Hazard: Failed Stability Specification: OOS low viscosity results discovered during retain testing.
January 17, 2018DrugsFDA
Akorn Inc recalls Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Ph
Hazard: CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
August 23, 2017DrugsFDA
Akorn Inc recalls Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
August 23, 2017DrugsFDA
Akorn Inc recalls Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufacture
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
August 23, 2017DrugsFDA
Akorn Inc recalls Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (
Hazard: Crystallization with subpotent out of specification assay results for chlorhexidine.
May 17, 2017DrugsFDA
Akorn, Inc. recalls IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powd
Hazard: Product is being recalled due to low pH value.
May 10, 2017DrugsFDA
Akorn Inc recalls Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 m
Hazard: Failed Dissolution Specifications
April 19, 2017DrugsFDA
Akorn, Inc. recalls LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, I
Hazard: Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
November 30, 2016DrugsFDA
Akorn Inc recalls Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Ver
Hazard: Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
November 9, 2016DrugsFDA
Akorn Inc recalls Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-6
Hazard: Subpotent Drug: concentration of product is less than labeled amount.
August 31, 2016DrugsFDA
Akorn, Inc. recalls Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Mariet
Hazard: Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
June 8, 2016DrugsFDA
Akorn, Inc. recalls Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest,
Hazard: Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
June 1, 2016DrugsFDA
Akorn, Inc. recalls PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured
Hazard: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
June 1, 2016DrugsFDA
Akorn, Inc. recalls Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH
Hazard: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
June 1, 2016DrugsFDA
Akorn, Inc. recalls ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for
Hazard: Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
May 11, 2016DrugsFDA
Akorn, Inc. recalls Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle
Hazard: Presence of Particulate Matter