Akorn, Inc.

Complete recall history across all FDA and CPSC categories — 176 total recalls

Akorn, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (176)

FDA drug safety enforcement actions by Akorn, Inc.. Showing most recent 50.

Date Product Reason Class
Apr 26, 2023 Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx O... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intraveno... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TEC... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous U... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manuf... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured b... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Dis... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, D... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Op... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn O... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operatin... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL amp... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distrib... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, R... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Di... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distr... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manu... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL S... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, D... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distribute... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 m... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufa... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile,... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 ... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Di... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramu... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distrib... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distribut... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc.... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes,... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II
Apr 26, 2023 Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottl... CGMP Deviations: Firm went out of business and could no longer continue stabi... Class II

View all 176 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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