Sandoz, Inc

FDA Regulatory Profile

Summary

Total Recalls
42 (3 Class I)
510(k) Clearances
0
Inspections
18
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0651-2025Class IICyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple DSeptember 5, 2025
D-0626-2025Class IICiprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, ManufactureAugust 13, 2025
D-0569-2025Class ICefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx OnlJune 27, 2025
D-0570-2025Class IBuffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, June 27, 2025
D-0753-2022Class IIOrphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by SanMarch 21, 2022
D-0286-2022Class IEnoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, FNovember 17, 2021
D-1259-2020Class IIInfuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2,April 21, 2020
D-0162-2020Class IIINeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL boOctober 17, 2019
D-0163-2020Class IIIGatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, MaOctober 17, 2019
D-0161-2020Class IIIBimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, SterileOctober 17, 2019
D-0127-2020Class IISandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. PrincSeptember 23, 2019
D-0128-2020Class IISandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. PrinSeptember 23, 2019
D-0129-2020Class IISandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. PrincSeptember 23, 2019
D-0258-2019Class IIIsosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. PriNovember 2, 2018
D-0260-2019Class IIIsosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., PriNovember 2, 2018
D-0259-2019Class IIIsosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., PrinNovember 2, 2018
D-0261-2019Class IIIsosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., PriNovember 2, 2018
D-0262-2019Class IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, ManufaNovember 2, 2018
D-0257-2019Class IIINitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles November 2, 2018
D-0359-2019Class IISandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, RxNovember 1, 2018