Sandoz recalls

Sandoz has 59 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 24 Jun 2026. 6 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls59since 2012

Last 12 months1reported

Class I47% of total

Ongoing6latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 2 0Aug 2 0 0Nov 0 0 0Feb 0 0 0May 1 0 0Aug 0 0

Severity split

Class I 4 7%Class II 28 47%Class III 27 46%

Why sandoz is recalled

Product types

Brands

By year

202612%
202547%
202212%
202112%
202012%
2019610%
2018814%
2017712%
20161017%
201512%

Ongoing sandoz recalls

6 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS III	Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin	Sandoz	Other	Nationwide
24 Sep 2025Drug	CLASS II	Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide	Sandoz	Manufacturing (CGMP) Deviations	Nationwide
17 Sep 2025Drug	CLASS II	Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone	Sandoz	Temperature Abuse	CA
9 Jul 2025Drug	CLASS I	Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium	Sandoz	Labeling Errors	Nationwide
9 Jul 2025Drug	CLASS I	Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin	Sandoz	Packaging Defects	Nationwide
5 Dec 2018Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg recalled	Sandoz	Nitrosamine Impurity	OH, PR

All sandoz recalls, newest first

59 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS III	Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin	Sandoz	Other	Nationwide
24 Sep 2025Drug	CLASS II	Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide	Sandoz	Manufacturing (CGMP) Deviations	Nationwide
17 Sep 2025Drug	CLASS II	Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone	Sandoz	Temperature Abuse	CA
9 Jul 2025Drug	CLASS I	Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium	Sandoz	Labeling Errors	Nationwide
9 Jul 2025Drug	CLASS I	Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin	Sandoz	Packaging Defects	Nationwide
13 Apr 2022Drug	CLASS II	Orphenadrine Citrate Extended-Release Tablets, USP 100 mg recalledOrphenadrine Citrate	Sandoz	Nitrosamine Impurity	Nationwide
8 Dec 2021Drug	CLASS I	Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz	Sandoz	Temperature Abuse	Nationwide
13 May 2020Drug	CLASS II	Infuvite PEDiatric Pharmacy, kit in 1 carton fill recalled by SandozInfuvite Pediatric	Sandoz	Other	Nationwide
6 Nov 2019Drug	CLASS III	Bimatoprost Ophthalmic Solution recalled by SandozBimatoprost	Sandoz	Packaging Defects	Nationwide
6 Nov 2019Drug	CLASS III	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recalledGatifloxacin	Sandoz	Packaging Defects	Nationwide
6 Nov 2019Drug	CLASS III	Neomycin and Polymyxin B Sulfates recalled by SandozNeomycin And Polymyxin B Sulfates And Dexamethasone	Sandoz	Packaging Defects	Nationwide
16 Oct 2019Drug	CLASS II	Ranitidine Hydrochloride Capsules 300mg recalled by Sandoz	Sandoz	Nitrosamine Impurity	Nationwide
16 Oct 2019Drug	CLASS II	Ranitidine Hydrochloride Capsules 150mg recalled by Sandoz	Sandoz	Nitrosamine Impurity	Nationwide
16 Oct 2019Drug	CLASS II	Ranitidine Hydrochloride Capsules 150mg recalled by Sandoz	Sandoz	Nitrosamine Impurity	Nationwide
5 Dec 2018Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg recalled	Sandoz	Nitrosamine Impurity	OH, PR
21 Nov 2018Drug	CLASS II	Isosorbide Dinitrate Tablets, USP 5 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018Drug	CLASS II	Isosorbide Dinitrate Tablets, USP 20 mg recalled by SandozIsosorbide Dinitrate	Sandoz	Other	Nationwide
21 Nov 2018Drug	CLASS II	Isosorbide Dinitrate Tablets, USP 10 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018Drug	CLASS II	Isosorbide Dinitrate Tablets, USP 20 mg recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018Drug	CLASS III	Nitrofurantoin Capsules recalled by Sandoz	Sandoz	Other	Nationwide
21 Nov 2018Drug	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalledNitrofurantoin (monohydrate/macrocrystals)	Sandoz	Packaging Defects	Nationwide
25 Apr 2018Drug	CLASS III	Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg recalled	Sandoz	Other	Nationwide
4 Oct 2017Drug	CLASS III	Ampicillin for Injection, USP, 500 mg per vial, single vial recalledAmpicillin	Sandoz	Labeling Errors	Nationwide
12 Jul 2017Drug	CLASS III	Amitriptyline HCl Tablets, USP 25 mg recalled by Sandoz IncorporatedAmitriptyline Hydrochloride	Sandoz	Packaging Defects	Nationwide
7 Jun 2017Drug	CLASS III	Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg recalledAmoxicillin And Clavulanate Potassium	Sandoz	Potency & Assay	NY, OH
15 Mar 2017Drug	CLASS II	Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg recalled by Sandoz	Sandoz	Potency & Assay	Nationwide
1 Mar 2017Drug	CLASS II	Transderm Scop (scopolamine) Transdermal System, 1.5 mg recalled	Sandoz	Packaging Defects	Nationwide
25 Jan 2017Drug	CLASS III	Donepezil Hydrochloride Tablets, 10 mg recalled by Sandoz	Sandoz	Potency & Assay	Nationwide
4 Jan 2017Drug	CLASS II	Nadolol Tablets, USP, 40mg recalled by Sandoz Incorporated	Sandoz	Potency & Assay	MS, OH
30 Nov 2016Drug	CLASS III	Ceftriaxone for Injection, USP use Vials recalled by SandozCeftriaxone Sodium	Sandoz	Labeling Errors	WI

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.