Sandoz recalls

Sandoz has 43 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 24 Jun 2026. 6 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls43since 2013

Last 12 months2reported

Class I37% of total

Ongoing6latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 2Jul 0 2 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 0Jul 0 0

Severity split

Class I 3 7%Class II 22 51%Class III 18 42%

Why sandoz is recalled

Product types

Brands

By year

202612%
202549%
202212%
202112%
202012%
2019614%
2018716%
2017512%
20161023%
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	Sterility	Nationwide
17 Sep 2025Drug	CLASS II	Ciprofloxacin 3% and Dexamethasone 1% Otic Suspension recalled by SandozCiprofloxacin 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	Sterility	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

43 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	Sterility	Nationwide
17 Sep 2025Drug	CLASS II	Ciprofloxacin 3% and Dexamethasone 1% Otic Suspension recalled by SandozCiprofloxacin 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	Sterility	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	Sterility	Nationwide
6 Nov 2019Drug	CLASS III	Gatifloxacin Ophthalmic Solution 5%, For Use in the Eyes Only recalledGatifloxacin	Sandoz	Sterility	Nationwide

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.