Sandoz Inc: 39 recalls on record

Recalls filed with 1 agency: FDA (39).

First recall on record: November 13, 2013. Most recent: June 24, 2026.

Risk classification: Class I: 3 · Class II: 19 · Class III: 17

Most recent recalls

DateAgencyProduct
June 24, 2026FDAFocalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx onl…D-0608-2026
September 24, 2025FDACyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL…D-0651-2025
September 17, 2025FDACiprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, …D-0626-2025
July 9, 2025FDACefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous …D-0569-2025
July 9, 2025FDABuffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), F…D-0570-2025
April 13, 2022FDAOrphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufact…D-0753-2022
December 8, 2021FDAEnoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safet…D-0286-2022
May 13, 2020FDAInfuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL)…D-1259-2020
November 6, 2019FDANeomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Steri…D-0162-2020
November 6, 2019FDAGatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL…D-0163-2020
October 16, 2019FDASandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sando…D-0128-2020
October 16, 2019FDASandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz…D-0127-2020
December 5, 2018FDASandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count …D-0359-2019
November 21, 2018FDANitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx O…D-0262-2019
November 21, 2018FDAIsosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sando…D-0261-2019
November 21, 2018FDAIsosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sando…D-0260-2019
November 21, 2018FDANitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsu…D-0257-2019
October 4, 2017FDAAmpicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged i…D-1179-2017
June 7, 2017FDAAmoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, R…D-0868-2017
March 15, 2017FDAPioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufac…D-0515-2017
March 1, 2017FDATransderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208…D-0481-2017
January 25, 2017FDADonepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31…D-0435-2017
November 30, 2016FDACeftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use,…D-0145-2017
November 23, 2016FDAL-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC…D-0141-2017
November 23, 2016FDAL-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (…D-0140-2017

Questions about this company

How many recalls does Sandoz Inc have?
Recalert has 39 U.S. recalls on record for Sandoz Inc, published between November 13, 2013 and June 24, 2026.
What was the most recent Sandoz Inc recall?
FDA recall D-0608-2026, published June 24, 2026: Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Which agencies have handled Sandoz Inc recalls?
Sandoz Inc appears as the recalling firm in recalls from: FDA (39).

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