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.

151–175 of 192

  • SevereFDA (Drugs)·D-0993-2019·2019-03-20

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling Gentamicin Sulfate Ophthalmic Solution, 0.3%, due to high out-of-specification impurities found during stability testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2019·2019-02-27

    Akorn Recalls Clobetasol Propionate Cream Due to Preservative Stability Failure

    Akorn Inc. is recalling specific lots of Clobetasol Propionate Emollient Cream 0.05% because stability testing revealed out-of-specification preservative levels.

    Product
    Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0511-2019·2019-02-27

    Akorn Recalls Moisturizing Lubricant Eye Drops Due to Stability Failure

    Akorn Inc is recalling specific lots of Moisturizing Lubricant Eye Drops because they failed stability specifications for Sodium Perborate.

    Product
    Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0483-2019·2019-02-20

    Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures

    Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.

    Product
    COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0414-2019·2019-02-06

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1208-2019·2018-12-05

    Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

    Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

    Product
    Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1183-2018·2018-09-12

    Akorn Recalls Ethosuximide Capsules Due to Impurity Failures

    Akorn, Inc. is recalling Ethosuximide Capsules, 250 mg, due to out-of-specification results for an unspecified impurity.

    Product
    Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1168-2018·2018-09-05

    Akorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities

    Akorn, Inc. is recalling specific lots of Azelastine HCl Ophthalmic Solution 0.05% because of out-of-specification results for Azelastine N-oxide.

    Product
    Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2018·2018-08-15

    Akorn Recalls Lidocaine and Prilocaine Cream Due to Impurity

    Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.

    Product
    Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0916-2018·2018-07-18

    Akorn Recalls Acetylcysteine for Injection Due to Manufacturing Deviations

    Akorn, Inc. is recalling 89,507 vials of Acetylcysteine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is classified as FDA Class II.

    Product
    Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0612-2018·2018-04-04

    Akorn Recalls 24-Hour Oral Care Kits Due to Low Chlorhexidine Levels

    Akorn, Inc. is recalling 24-Hour Oral Care q2 Kits because the chlorhexidine gluconate oral rinse contained in some units had low potency levels.

    Product
    24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0611-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Gluconate Oral Rinse Unit Dose Cups

    Akorn, Inc. is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups due to product crystallization and low assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0617-2018·2018-03-28

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

    Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

    Product
    Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0577-2018·2018-03-14

    Akorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure

    Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution because testing revealed low viscosity results.

    Product
    Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0211-2018·2018-01-17

    Akorn Recalls Gabapentin Oral Solution Due to Unapproved Manufacturer

    Akorn Inc is recalling 4,885 bottles of Gabapentin Oral Solution because the product was released with an unapproved active ingredient manufacturer.

    Product
    Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1088-2017·2017-08-23

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Crystallization

    Akorn Inc is recalling Chlorhexidine Gluconate Oral Rinse unit dose cups because crystallization caused subpotent assay results.

    Product
    Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1090-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1089-2017·2017-08-23

    Akorn Recalls Halyard Chlorhexidine Oral Rinse Due to Crystallization

    Akorn Inc is recalling Halyard 24-Hour Oral Care Kits containing chlorhexidine gluconate oral rinse due to crystallization and subpotent assay results.

    Product
    Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0697-2017·2017-05-17

    Akorn Recalls IC-Green Injection Kits Due to Low pH Value

    Akorn, Inc. is recalling 1,292 kits of IC-Green (indocyanine green for injection) due to low pH values. The product was distributed nationwide.

    Product
    IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2017·2017-05-10

    Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failures

    Akorn Inc is recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension because the product failed to meet dissolution specifications.

    Product
    Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0661-2017·2017-04-19

    Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues

    Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.

    Product
    LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0152-2017·2016-11-30

    Akorn Recalls Desoximetasone Ointment for Stability Failures

    Akorn Inc. is recalling Desoximetasone Ointment USP, 0.25%, due to failed stability specifications and phase separation.

    Product
    Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0124-2017·2016-11-09

    Akorn Recalls Subpotent Sodium Chloride Ophthalmic Solution

    Akorn Inc. is recalling 29,972 bottles of 5% Sodium Chloride Ophthalmic Solution because the product concentration is less than the labeled amount.

    Product
    Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1469-2016·2016-08-31

    Akorn Recalls Desoximetasone Gel Due to Impurity Specification Failure

    Akorn, Inc. is recalling Desoximetasone Gel USP, 0.05%, because the product failed impurity specifications at the 9-month stability time point.

    Product
    Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Manufactured by: Ei LLC Kannapolis, NC 28083, NDC 61748-205-60.
    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.