Brand

Akorn, Inc. Recalls

192 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Akorn, Inc..

192Total Recalls
0Critical
18.8MUnits Affected
Apr 26, 2023Most Recent
All Recalls

Every Akorn, Inc. Recall

Sorted by most recent. Click any recall for full details.

192 recalls
RecallFDA
Akorn, Inc.
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 V...
Injectable Drugs·8,187 affected·Aug 6, 2019
RecallFDA
Akorn, Inc.
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....
Injectable Drugs·648 affected·Aug 6, 2019
RecallFDA
Akorn Inc
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distribut...
Oral Drugs·16,216 affected·Jun 7, 2019
RecallFDA
Akorn Inc
Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lak...
Injectable Drugs·5,380 affected·Apr 23, 2019
RecallFDA
Akorn, Inc.
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 5...
Oral Drugs·2,796 affected·Mar 28, 2019
High RiskFDA
Akorn Inc
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. ...
Drugs·15,322 affected·Mar 12, 2019
High RiskFDA
Akorn, Inc.
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-...
Ophthalmic Drugs·51,456 affected·Feb 22, 2019
High RiskFDA
Akorn Inc
Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerf...
Ophthalmic Drugs·78,120 affected·Feb 4, 2019
RecallFDA
Akorn Inc
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...
Topical Drugs·4,896 affected·Jan 25, 2019
RecallFDA
Akorn Inc
COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distribute...
Ophthalmic Drugs·30,794 affected·Dec 20, 2018
RecallFDA
Akorn, Inc.
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 28...
Topical Drugs·58,393 affected·Oct 29, 2018
High RiskFDA
Akorn, Inc.
Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 1...
Ophthalmic Drugs·149,159 affected·Oct 8, 2018
High RiskFDA
Akorn, Inc.
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss ...
Oral Drugs·23,788 affected·Aug 24, 2018
RecallFDA
Akorn, Inc.
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...
Ophthalmic Drugs·8,574 affected·Aug 8, 2018
High RiskFDA
Akorn, Inc.
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 503...
Topical Drugs·22,605 affected·Aug 1, 2018
High RiskFDA
Akorn, Inc.
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Injectable Drugs·89,507 affected·Jun 22, 2018
RecallFDA
Akorn, Inc.
24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0...
Oral Drugs·48,176 affected·Mar 29, 2018
RecallFDA
Akorn, Inc.
24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0...
Oral Drugs·20,587 affected·Mar 29, 2018
Medium RiskFDA
Akorn, Inc.
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 (ND...
Oral Drugs·561,800 affected·Mar 29, 2018
RecallFDA
Akorn, Inc.
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured b...
Drugs·4,128 affected·Mar 9, 2018
RecallFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC...
Ophthalmic Drugs·31,812 affected·Feb 21, 2018
RecallFDA
Akorn Inc
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....
Oral Drugs·4,885 affected·Dec 15, 2017
RecallFDA
Akorn Inc
Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Heal...
Oral Drugs·40,978 affected·Jul 12, 2017
Medium RiskFDA
Akorn Inc
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)...
Oral Drugs·541,900 affected·Jul 12, 2017
Medium RiskFDA
Akorn Inc
Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Heal...
Oral Drugs·101,952 affected·Jul 12, 2017
RecallFDA
Akorn, Inc.
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Man...
Injectable Drugs·1,292 affected·Apr 20, 2017
High RiskFDA
Akorn, Inc.
LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest,...
Ophthalmic Drugs·107,940 affected·Mar 17, 2017
High RiskFDA
Akorn Inc
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARM...
Oral Drugs·55,968 affected·Mar 13, 2017
High RiskFDA
Akorn Inc
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 ...
Topical Drugs·62 affected·Nov 14, 2016
High RiskFDA
Akorn Inc
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Ophthalmic Drugs·29,972 affected·Oct 21, 2016
RecallFDA
Akorn, Inc.
Desoximetasone Gel USP, 0.05%, packaged in 60 gram aluminum tubes, Rx only, Marketed by: VersaPharm Incorporated Marietta, GA 30062, Man...
Topical Drugs·4,045 affected·Jul 27, 2016
High RiskFDA
Akorn, Inc.
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC ...
Ophthalmic Drugs·57,920 affected·May 17, 2016
High RiskFDA
Akorn, Inc.
Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0.4% / Propylene Glycol 0.3%), 15 ml bottle, Distributed by ...
Ophthalmic Drugs·10,060 affected·Apr 7, 2016
High RiskFDA
Akorn, Inc.
Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., IN...
Oral Drugs·3,112,657 affected·Mar 23, 2016
High RiskFDA
Akorn, Inc.
PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental...
Oral Drugs·294,090 affected·Mar 23, 2016
High RiskFDA
Akorn, Inc.
ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Profess...
Oral Drugs·33,862 affected·Mar 23, 2016
RecallFDA
Akorn, Inc.
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech P...
Drugs·13,896 affected·Aug 21, 2015
RecallFDA
Akorn, Inc.
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
Injectable Drugs·6,861 affected·Aug 20, 2015
RecallFDA
Akorn, Inc.
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 ...
Injectable Drugs·370 affected·Apr 20, 2015
High RiskFDA
Akorn, Inc.
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc....
Oral Drugs·0 affected·Apr 7, 2015
High RiskFDA
Akorn, Inc.
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA...
Oral Drugs·424,174 affected·Apr 7, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx ...
Oral Drugs·8,400 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16)...
Oral Drugs·326,666 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16...
Oral Drugs·27,648 affected·Mar 17, 2015
High RiskFDA
Akorn, Inc.
Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuatio...
Inhaled / Nasal Drugs·44,448 affected·Feb 27, 2015
High RiskFDA
Akorn, Inc.
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, M...
Drugs·23,449 affected·Jan 28, 2015
RecallFDA
Akorn, Inc.
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Drugs·3,937 affected·Dec 9, 2014
RecallFDA
Akorn, Inc.
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mf...
Injectable Drugs·5,539 affected·Aug 5, 2014