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.

176–192 of 192

  • SevereFDA (Drugs)·D-0949-2016·2016-06-08

    Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns

    Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.

    Product
    Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2016·2016-06-01

    Akorn Recalls PerioRx Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling PerioRx oral rinse because multiple batches failed impurity specifications. The product contains an unknown impurity of chlorhexidine gluconate.

    Product
    PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2016·2016-06-01

    Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

    Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

    Product
    ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0835-2016·2016-05-11

    Akorn Recalls PEG-Phen Lubricant Eye Drops Due to Particulate Matter

    Akorn, Inc. is recalling specific batches of PEG-Phen Lubricant Eye Drops because they contain particulate matter. Consumers should stop using the affected products.

    Product
    Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-199-05, ALSO labeled as Premier Value Brand PEG-Phen Lubricant Eye D
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0295-2016·2015-11-25

    Akorn Recalls Hydrocortisone Otic Solution Due to Missing Safety Seal

    Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the safety seal around the neck.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0231-2016·2015-11-25

    Akorn Recalls RIFAMPIN FOR INJECTION Due to Impurity Specifications

    Akorn, Inc. is recalling 6,861 vials of RIFAMPIN FOR INJECTION USP, 600 mg because a known impurity failed to meet specifications.

    Product
    RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1429-2015·2015-09-23

    Akorn Recalls IC-Green Injection Kits Due to Low Potency

    Akorn, Inc. is recalling 370 kits of IC-Green (indocyanine green for injection) because a low out-of-specification potency result was found.

    Product
    IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) pe
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurities

    Akorn, Inc. is recalling Hydroxyzine Hydrochloride oral solution because it failed impurities and degradation specifications. The product was distributed nationwide, including Puerto Rico.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2015·2015-06-17

    Akorn Recalls Hydroxyzine Hydrochloride Oral Solution Due to Impurity Failures

    Akorn, Inc. is recalling 424,174 bottles of Hydroxyzine Hydrochloride oral solution because the product failed impurities and degradation specifications.

    Product
    Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0997-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling 8,400 cups of Sulfamethoxazole and Trimethoprim oral suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0995-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0996-2015·2015-05-20

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failure

    Akorn, Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim Oral Suspension because the sulfamethoxazole component failed to meet dissolution specifications.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0405-2015·2015-03-11

    Akorn Recalls Fluticasone Nasal Spray Due to Preservative Failure

    Akorn, Inc. is recalling Fluticasone Propionate Nasal Spray because the preservative benazalkonium chloride failed to meet stability specifications.

    Product
    Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinoi
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2015·2015-02-18

    Akorn Recalls Erythromycin Pledgets Due to Microbial Contamination

    Akorn, Inc. is recalling Erythromycin Pledgets USP, 2%, 60-count jars because the active pharmaceutical ingredient failed USP microbial tests.

    Product
    Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0333-2015·2015-01-14

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Specification Failure

    Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% because a known impurity exceeded specifications at the 12-month stability point.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1571-2014·2014-10-01

    Akorn Recalls Rifampin for Injection Due to Impurity Specification Failure

    Akorn, Inc. is recalling 5,539 vials of Rifampin for Injection USP, 600 mg, because a stability test showed an impurity level exceeding specifications.

    Product
    Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
    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.