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Akorn, Inc.

Akorn, Inc. Recalls

All product recalls associated with Akorn, Inc..

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Recall Summary

Total Recalls

192

Past Year

Class I (Serious)

Most Recent

Apr 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 192 recalls

Fluticasone Nasal Spray (Akorn) - Defective Dispenser (2022)

Defective container: defect prevents product from dispensing as intended.

Class IIModerate

FDAJun 13, 2022Nationwide• Akorn, Inc.

Calcipotriene Scalp Solution (Akorn) - Defective Delivery (2022)

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Class IIModerate

FDAJun 10, 2022Nationwide• Akorn, Inc.

Lidocaine Oral Solution (Akorn) – Viscosity Specification Failure (2022)

Failed viscosity specification - product was below specificcation

Class IIILow

FDAApr 15, 2022Nationwide• Akorn, Inc.

Sufentanil Injection (Akorn) – Subpotent Drug (2022)

Subpotent Drug: Out of specification for assay at the 30-month stability timepoint.

Class IIModerate

FDAJan 5, 2022Nationwide• Akorn, Inc.

Oxycodone Hydrochloride Solution (Akorn) - Missing Label (2021)

Labeling: Missing Label

Class IIILow

FDADec 3, 2021Nationwide• Akorn, Inc.

Morphine Sulfate Oral Solution (Akorn) – Missing Label Information (2021)

Labeling: Missing Label

Class IIILow

FDADec 3, 2021Nationwide• Akorn, Inc.

Betaxolol Ophthalmic Solution (Akorn) – Microbial Contamination (2021)

Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

Class IIModerate

FDAOct 4, 2021Nationwide• Akorn, Inc.

TheraTears Extra Eye Drops (Akorn) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDASep 8, 2021Nationwide• Akorn, Inc.

Betamethasone Dipropionate Lotion 0.05% (Akorn) – Impurity Specification (2021)

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

Class IIModerate

FDAAug 13, 2021Nationwide• Akorn, Inc.

Artificial Tears Ointment (Akorn) – Sterility Issue (2021)

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.

Class IIModerate

FDAAug 2, 2021Nationwide• Akorn, Inc.

Gabapentin Oral Solution (Akorn) – impurity specifications (2021)

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

Class IIModerate

FDAMar 8, 2021Nationwide• Akorn, Inc.

Levetiracetam Oral Solution (Akorn) – Leaking Bottle (2020)

Defective container: Customer complaints for oral solution leaking from bottles.

Class IIModerate

FDADec 28, 2020Nationwide• Akorn, Inc.

Eye Itch Relief (Akorn) – CGMP Deviation (2020)

CGMP Deviations

Class IIModerate

FDASep 3, 2020Nationwide• Akorn, Inc.

Prednisolone Sodium Phosphate (Akorn) – Discoloration Issue (2020)

Discoloration: Out of Specification (OOS) result for APHA Color Test.

Class IIILow

FDAJun 5, 2020Nationwide• Akorn, Inc.

Fentanyl Citrate Injection (Akorn) – Impurity Specification Failure (2020)

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

Class IIILow

FDAMar 25, 2020Nationwide• Akorn Inc

Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)

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.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

Walgreens Sodium Chloride Ointment (Akorn) – Particulate Matter (2020)

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.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

Sodium Chloride Ophthalmic Ointment (Akorn) – Particulate Matter (2020)

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.

Class IIILow

FDAFeb 21, 2020Nationwide• Akorn, Inc.

Proparacaine Ophthalmic Solution (Akorn) – Chemical Contamination (2019)

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Class IIILow

FDADec 26, 2019Nationwide• Akorn, Inc.

Hydrocortisone Acetic Acid Otic Solution (Akorn) – Low Assay Results (2019)

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Class IIModerate

FDADec 16, 2019Nationwide• Akorn Inc

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