The Recall Desk

Manufacturer

Akorn, Inc.

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

What the numbers show

Total
192
Critical
0
Severe
10
Most recent
2023-06-07

Of the 192 recalls from Akorn, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) are Severe.

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.

126–150 of 192

  • 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
  • SevereFDA (Drugs)·D-0004-2022·2021-10-13

    Betaxolol Ophthalmic Solution Recalled for Sterility Failure

    Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.

    Product
    Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0802-2021·2021-09-22

    Betamethasone Dipropionate Lotion recalled for unknown impurity

    Akorn, Inc. is recalling Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, due to an unknown impurity found in the product that exceeds specification limits. The affected lots were distributed nationwide.

    Product
    Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0786-2021·2021-09-08

    Akorn Artificial Tears Ointment Recalled for Non-Sterility

    Akorn, Inc. is recalling Artificial Tears Ointment eye lubricant due to failure of sterility testing. The product may be contaminated with Bacillus cereus.

    Product
    Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2021·2021-03-24

    Akorn Recalls Gabapentin Oral Solution Due to Impurity Specifications

    Akorn, Inc. is recalling Gabapentin Oral Solution because it failed impurity specifications during stability testing. The product was distributed nationwide.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2021·2021-01-20

    Akorn Recalls Levetiracetam Oral Solution Due to Leaking Bottles

    Akorn, Inc. is recalling specific lots of Levetiracetam Oral Solution because customer complaints reported the liquid leaking from the bottles.

    Product
    Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1628-2020·2020-10-07

    Akorn Recalls Eye Itch Relief Eye Drops Due to Manufacturing Deviations

    Akorn, Inc. is voluntarily recalling 25,843 bottles of Eye Itch Relief eye drops due to CGMP deviations. The product was distributed nationwide in 14 states.

    Product
    Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1388-2020·2020-07-22

    Akorn Recalls Proparacaine Hydrochloride Ophthalmic Solution Due to Chemical Contamination

    Akorn, Inc. is recalling Proparacaine Hydrochloride Ophthalmic Solution, 0.5%, due to chemical contamination from equipment cleaning residue.

    Product
    Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1340-2020·2020-06-17

    Akorn Recalls Prednisolone Sodium Phosphate Oral Solution Due to Discoloration

    Akorn, Inc. is recalling specific lots of Prednisolone Sodium Phosphate Oral Solution because the product failed a color test.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1258-2020·2020-04-08

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because retained sample testing showed total impurities exceeded the allowed limit.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0859-2020·2020-03-04

    Akorn Recalls Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown particulate matter inside the tubes.

    Product
    Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0861-2020·2020-03-04

    CVS Health Sodium Chloride Ophthalmic Ointment Recalled for Particulate Matter

    Akorn, Inc. is recalling CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper inside the tubes.

    Product
    CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0860-2020·2020-03-04

    Akorn Recalls Well at Walgreens Sodium Chloride Ophthalmic Ointment Due to Particulate Matter

    Akorn, Inc. is recalling specific tubes of Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, due to the presence of brown spots identified as tin with trace copper.

    Product
    Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0839-2020·2020-02-19

    Akorn Recalls Subpotent Hydrocortisone and Acetic Acid Otic Solution

    Akorn Inc is recalling 16,078 bottles of Hydrocortisone and Acetic Acid Otic Solution due to low assay results for the hydrocortisone component.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0647-2020·2020-01-08

    Akorn Recalls Myorisan 20mg Capsules Due to Mispackaging Error

    Akorn, Inc. is recalling Myorisan (isotretinoin) 20mg capsules because some cartons contained 40mg blister cards. The error was found in a customer complaint.

    Product
    MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1883-2019·2019-10-09

    Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.

    Product
    Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1878-2019·2019-10-02

    Akorn Recalls Lidocaine Hydrochloride Jelly Due to Metal Particulate Finding

    Akorn, Inc. is recalling Lidocaine Hydrochloride Jelly USP, 2% due to a finding of metal particulate matter in the filling room. No particulates were identified in the product itself.

    Product
    Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1840-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Fill Volume and Impurity Issues

    Akorn, Inc. is recalling 648 vials of Eptifibatide Injection because the fill volume was below specification and a known impurity exceeded limits.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1839-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling 4,085 vials of Eptifibatide Injection because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1841-2019·2019-09-04

    Akorn Recalls Eptifibatide Injection Vials Due to Impurity

    Akorn, Inc. is recalling Eptifibatide Injection vials because they failed impurity specifications for D-aspartic acid.

    Product
    Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1392-2019·2019-06-26

    Akorn Recalls Myorisan Isotretinoin Capsules Due to Labeling Error

    Akorn Inc. is recalling 16,216 cartons of Myorisan isotretinoin capsules because secondary cartons incorrectly state 40 mg instead of 30 mg.

    Product
    Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1241-2019·2019-05-01

    Akorn Recalls Fentanyl Citrate Injection Due to Impurity Specification Failure

    Akorn Inc. is recalling Fentanyl Citrate Injection, USP, 100 mcg/2 mL, because it failed impurity specifications during stability testing.

    Product
    Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1080-2019·2019-04-10

    Akorn Recalls Nystatin Oral Suspension Due to Unknown Impurity

    Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.

    Product
    Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1011-2019·2019-03-27

    Akorn Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Low Potency

    Akorn Inc is recalling Hydrocortisone and Acetic Acid Otic Solution because routine stability testing revealed the drug was sub-potent.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Akorn

American generic pharmaceuticals manufacturer

Country
United States

Official website

Source: Wikidata (Q20539236), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.