FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Akorn, Inc. — RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, I…Class III · 2015-08-20
Akorn, Inc. — Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application…Class III · 2023-01-30
Akorn, Inc. — Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydroco…Class III · 2015-08-21
Akorn, Inc. — Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four u…Class II · 2021-03-08
Akorn, Inc. — Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the followi…Class III · 2014-12-09
Akorn, Inc. — Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottl…Class III · 2021-12-03
Akorn, Inc. — Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 5…Class III · 2021-12-03
Akorn, Inc. — Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by …Class II · 2015-01-28
Akorn, Inc. — Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber …Class II · 2015-02-27
Akorn, Inc. — Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle…Class II · 2018-10-08
Akorn, Inc. — Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intrav…Class II · 2022-01-05
Akorn, Inc. — Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile…Class III · 2018-02-21
Akorn, Inc. — Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC …Class III · 2018-03-29
Akorn, Inc. — 24-HOUR Oral Care q2 Kit with Ballard* Technology, containing 2 Tooth…Class III · 2018-03-29
Akorn, Inc. — 24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Tooth…Class III · 2018-03-29
Akorn, Inc. — Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Mark…Class III · 2018-03-09
Akorn, Inc. — MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Cap…Class II · 2019-11-15
Akorn, Inc. — LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in …Class II · 2017-03-17
Akorn, Inc. — IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a…Class III · 2017-04-20
Akorn, Inc. — TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye …Class II · 2021-09-08
Akorn, Inc. — Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application…Class II · 2023-04-26
Akorn, Inc. — Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packa…Class II · 2023-04-26
Akorn, Inc. — Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by:…Class II · 2023-04-26
Akorn, Inc. — Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn …Class II · 2023-04-26
Akorn, Inc. — Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx…Class II · 2023-04-26
Akorn, Inc. — Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 …Class II · 2023-04-26
Akorn, Inc. — Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use…Class II · 2023-04-26
Akorn, Inc. — Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8…Class II · 2021-08-02
Akorn, Inc. — Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram…Class II · 2023-04-26
Akorn, Inc. — Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx …Class II · 2023-04-26
Akorn, Inc. — AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Oint…Class II · 2023-04-26
Akorn, Inc. — Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottl…Class II · 2023-04-26
Akorn, Inc. — Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: …Class II · 2023-04-26
Akorn, Inc. — Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one …Class II · 2023-04-26
Akorn, Inc. — Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Onl…Class II · 2023-04-26
Akorn, Inc. — Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Dist…Class II · 2023-04-26
Akorn, Inc. — Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b)…Class II · 2023-04-26
Akorn, Inc. — Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Dist…Class II · 2023-04-26
Akorn, Inc. — Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only,…Class II · 2023-04-26
Akorn, Inc. — Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only,…Class II · 2023-04-26
Akorn, Inc. — DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vi…Class II · 2023-04-26
Akorn, Inc. — Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampule…Class II · 2023-04-26
Akorn, Inc. — Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Via…Class II · 2023-04-26
Akorn, Inc. — DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles …Class II · 2023-04-26
Akorn, Inc. — Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in…Class II · 2021-08-13
Akorn, Inc. — Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules,…Class II · 2023-04-26
Akorn, Inc. — Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Dis…Class II · 2023-04-26
Akorn, Inc. — Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured…Class II · 2023-04-26
Akorn, Inc. — Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Onl…Class II · 2023-04-26
Akorn, Inc. — Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 …Class II · 2023-04-26
Akorn, Inc. — Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifene…Class II · 2023-04-26
Akorn, Inc. — Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx…Class II · 2023-04-26
Akorn, Inc. — HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For…Class II · 2023-04-26
Akorn, Inc. — Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx …Class II · 2023-04-26
Akorn, Inc. — Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packa…Class II · 2023-04-26
Akorn, Inc. — IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx O…Class II · 2023-04-26
Akorn, Inc. — Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged i…Class II · 2023-04-26
Akorn, Inc. — Lactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottle…Class II · 2023-04-26
Akorn, Inc. — Lactulose Solution, USP (For oral or rectal administration), 30 mL Un…Class II · 2023-04-26
Akorn, Inc. — Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, D…Class II · 2023-04-26
Akorn, Inc. — Levocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distribute…Class II · 2023-04-26
Akorn, Inc. — Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusi…Class II · 2023-04-26
Akorn, Inc. — Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, …Class II · 2023-04-26
Akorn, Inc. — Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufa…Class II · 2023-04-26
Akorn, Inc. — Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manuf…Class II · 2023-04-26
Akorn, Inc. — Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for…Class II · 2023-04-26
Akorn, Inc. — Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Ako…Class II · 2023-04-26
Akorn, Inc. — Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100m…Class II · 2023-04-26
Akorn, Inc. — Lorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile,…Class II · 2023-04-26
Akorn, Inc. — Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, …Class II · 2023-04-26
Akorn, Inc. — Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx O…Class II · 2023-04-26
Akorn, Inc. — Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intra…Class II · 2023-04-26
Akorn, Inc. — Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Onl…Class II · 2023-04-26
Akorn, Inc. — Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or …Class II · 2023-04-26
Akorn, Inc. — Neomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointm…Class II · 2023-04-26
Akorn, Inc. — Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufa…Class II · 2023-04-26
Akorn, Inc. — Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only…Class II · 2023-04-26
Akorn, Inc. — Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx O…Class II · 2023-04-26
Akorn, Inc. — Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Gly…Class II · 2016-04-07
Akorn, Inc. — Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles,…Class II · 2023-04-26
Akorn, Inc. — Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL an…Class II · 2023-04-26
Akorn, Inc. — Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg …Class II · 2023-04-26
Akorn, Inc. — Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx …Class II · 2023-04-26
Akorn, Inc. — Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Onl…Class II · 2023-04-26
Akorn, Inc. — Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Di…Class II · 2023-04-26
Akorn, Inc. — Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b)…Class II · 2023-04-26
Akorn, Inc. — Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL),…Class II · 2023-04-26
Akorn, Inc. — Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Man…Class II · 2023-04-26
Akorn, Inc. — Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufacture…Class II · 2023-04-26
Akorn, Inc. — Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles,…Class II · 2023-04-26
Akorn, Inc. — Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 …Class III · 2022-04-15
Akorn, Inc. — Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx…Class II · 2023-04-26
Akorn, Inc. — Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)…Class II · 2023-04-26
Akorn, Inc. — Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5…Class II · 2023-04-26
Akorn, Inc. — Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL b…Class II · 2023-04-26
Akorn, Inc. — Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampule…Class II · 2023-04-26
Akorn, Inc. — Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manuf…Class II · 2023-04-26
Akorn, Inc. — Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bot…Class II · 2023-04-26
Akorn, Inc. — Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Di…Class II · 2023-04-26
Akorn, Inc. — Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx onl…Class II · 2023-04-26