Akorn recalls
FDA enforcement reports naming Akorn Inc as the recalling firm.
- Recall reports
- 192
- Class I (serious)
- 0
- Most recent report
- Jun 7, 2023
- Jun 7, 2023Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACA…Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packa…Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Artificial Tears Solution, Polyvinyl Alcohol 1Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Azelastine Hydrochloride Nasal Spray, 0Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Co…Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Ciclopirox Topical Solution 8% (Nail Lacquer), 6Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Clobetasol Propionate Cream, USP, 0Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Clobetasol Propionate Ointment, USP, 0Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Jun 7, 2023Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous U…Drug · Akorn, Inc.CGMP Deviations: Firm went out of business and could no longer continue stability studies.Class II
- Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn…
- Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc
- Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a)…
- Levofloxacin Ophthalmic Solution, 0
- Lidocaine 2
- Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed b…
- Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles,…
- Sodium Chloride Ophthalmic Ointment, USP, 5%, 3
- Olopatadine HCl Ophthalmic Solution, USP, 0
- Ropivacaine Hydrochloride Injection USP, 0
- Tropicamide Ophthalmic Solution, USP 0
- Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bo…
- Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating C…
- Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company…
- Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed…
- Apraclonidine Ophthalmic Solution 0
- Calcipotriene Topical Solution, 0
- Cetrorelix Acetate for Injection, 0
- Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn…
- Clobetasol Propionate Shampoo, 0
- Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by:…
- DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Dist…
- Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules,…
- Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distri…
- DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Do…
- Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARM…
- Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by…
- Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only,…
- Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Code…
- Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institu…
- HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or…
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed…
- Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL amp…
- IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manu…
- Ketorolac Tromethamine Ophthalmic Solution, 0
- Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottle…
- Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx O…
- Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Ako…
- Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles,…
- Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc
- Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only,…
- Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distribut…
- Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2…
- Moxifloxacin HCl Ophthalmic Solution, USP, 0
- Naloxone Injection, USP 0
- Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3
- Olopatadine HCl Nasal Spray, 665 mcg, 30
- Olopatadine HCl Ophthalmic Solution, USP, 0
- Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed b…
- Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile,…
- Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottle…
- Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6
- Promethazine HCl Oral Solution, USP, 6
- Proparacaine HCl Ophthalmic Solution, USP 0
- Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akor…
- Ropivacaine Hydrochloride Injection USP, 0
- Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akor…
- Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: A…
- Sodium DIURIL (chlorothiazide sodium), 0
- Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2…
- Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles…
- Timolol Maleate Ophthalmic Solution, USP 0
- Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufa…
- Tobramycin Ophthalmic Solution, USP 0
- Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Di…
- Tropicamide Ophthalmic Solution, USP 0
- Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by:…
- Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn…
- XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1
- Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distribut…
- Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Co…
- Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Onl…
- Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile,…
- Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile,…
- AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3
- Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by:…
- Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL…
- PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0
- Proparacaine Hydrochloride Ophthalmic Solution, USP 0
- Sodium Chloride Ophthalmic Ointment, USP, 5%
- Timolol Maleate Ophthalmic Solution, USP, 0
- Tobramycin Ophthalmic Solution, USP, 0
- Tobramycin Ophthalmic Solution, USP, 0
- AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3
- Artificial Tears OINTMENT, Lubricant Eye Ointment
- Proparacaine Hydrochloride Ophthalmic Solution, USP 0
- Olopatadine HCl Ophthalmic Solution, USP 0
- Olopatadine HCl Ophthalmic Solution, USP 0
- Olopatadine HCl Ophthalmic Solution, USP 0
- Olopatadine HCL Ophthalmic Solution, USP 0
- Olopatadine HCl Ophthalmic Solution, USP 0
- Ofloxacin Ophthalmic Solution, USP 0
- Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP
- Moxifloxacin Ophthalmic Solution, USP, 0
- Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-711-10) x10…
- Levofloxacin Ophthalmic Solution 0
- Ketorolac Tromethamine Ophthalmic Solution, 0
- GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2
- Erythromycin Ophthalmic Ointment USP, 0
- ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0
- Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by:…
- Ciprofloxacin Ophthalmic Solution, USP 0
- Betaxolol Ophthalmic Solution, USP 0
- Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1
- Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operati…
- Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bott…
- Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: A…
- Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile
- Timolol Maleate Ophthalmic Solution, USP, 0
- PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMAC…
- Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass b…
- Calcipotriene Topical Solution, 0
- Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx…
- TheraTears Extra (sodium carboxymethylcellulose) 0
- Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural…
- Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx o…
- Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Te…
- Betaxolol Ophthalmic Solution, USP, 0
- Betamethasone Dipropionate Lotion USP (Augmented), 0
- Artificial Tears Ointment, Lubricant Eye Ointment
- Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per…
- Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHAR…
- Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0
- Proparacaine Hydrochloride Ophthalmic Solution, USP, 0
- Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH…
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL…
- CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3
- Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3
- Sodium Chloride Ophthalmic Ointment USP, 5%, 3
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TE…
- MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Pres…
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2
- Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by:…
- Eptifibatide Injection, 75 mg/100 mL (0
- Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial
- Eptifibatide Injection, 75 mg/100 mL (0
- Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules contai…
- Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL…
- Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TEC…
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, H…
- Gentamicin Sulfate Ophthalmic Solution, USP, 0
- Clobetasol Propionate Emollient Cream 0
- Moisturizing Lubricant Eye Drops, 0
- COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0
- Gentamicin Sulfate Ophthalmic Solution, USP 0
- Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget appli…
- Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPhar…
- Azelastine HCl Ophthalmic Solution 0
- Lidocaine 2
- Acetylcysteine for Injection 6 g/30 mL (200 mg/mL)
- Chlorhexidine Gluconate Oral Rinse, 0
- 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with C…
- 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Toothbrush Packs with C…
- Triamcinolone Acetonide Lotion, USP 0
- Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufac…
- Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only
- Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0
- Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0
- Chlorhexidine Gluconate Oral Rinse, 0
- IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing si…
- Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape…
- LATANOPROST OPHTHALMIC SOLUTION, 0
- Desoximetasone Ointment USP, 0
- Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0
- Desoximetasone Gel USP, 0
- Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd
- PerioRx (chlorhexidine gluconate), oral rinse, 0
- Chlorhexidine gluconate, oral rinse, 0
- ORIS (chlorhexidine gluconate), oral rinse, 0
- Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 0
- RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only
- Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and a…
- IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02
- Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx…
- Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx…
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLA…
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FL…
- SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FL…
- Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with…
- Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis…
- Triamcinolone Acetonide Lotion USP, 0
- Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx…
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