Akorn, Inc.: 171 recalls on record

Recalls filed with 1 agency: FDA (171).

First recall on record: October 1, 2014. Most recent: June 7, 2023.

Risk classification: Class II: 145 · Class III: 26

Most recent recalls

DateAgencyProduct
January 19, 2022FDAOxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx onl…D-0368-2022
January 19, 2022FDAMorphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech…D-0367-2022
October 13, 2021FDABetaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle,…D-0004-2022
September 22, 2021FDABetamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (ND…D-0802-2021
September 8, 2021FDAArtificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Ster…D-0786-2021
January 20, 2021FDALevetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMA…D-0221-2021
October 7, 2020FDAEye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distribute…D-1628-2020
July 22, 2020FDAProparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Ster…D-1388-2020
June 17, 2020FDAPrednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH P…D-1340-2020
April 8, 2020FDAFentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL e…D-1258-2020
March 4, 2020FDASodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., …D-0859-2020
March 4, 2020FDACVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS …D-0861-2020
March 4, 2020FDAWell at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed b…D-0860-2020
February 19, 2020FDAHydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH…D-0839-2020
January 8, 2020FDAMYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescr…D-0647-2020
October 2, 2019FDALidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Ak…D-1878-2019
June 26, 2019FDAMyorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containi…D-1392-2019
March 27, 2019FDAHydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-…D-1011-2019
February 27, 2019FDAClobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram…D-0515-2019
February 20, 2019FDACOSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10…D-0483-2019
December 5, 2018FDAClindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applica…D-1208-2019
September 12, 2018FDAEthosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm …D-1183-2018
September 5, 2018FDAAzelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx…D-1168-2018
August 15, 2018FDALidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Ph…D-1046-2018
July 18, 2018FDAAcetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., …D-0916-2018

Questions about this company

How many recalls does Akorn, Inc. have?
Recalert has 171 U.S. recalls on record for Akorn, Inc., published between October 1, 2014 and June 7, 2023.
Which agencies have handled Akorn, Inc. recalls?
Akorn, Inc. appears as the recalling firm in recalls from: FDA (171).

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