DrugSep 24, 2025
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug recall — FDA D-0651-2025
cGMP deviations: Temperature excursion during transportation.
Class IIFDA: OngoingSandoz Inc
Recall history in this database
Classification mix: Class III: 18, Class II: 13, Class I: 4.
DrugJul 9, 2025
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use recall — FDA D-0569-2025
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained…
Class IFDA: OngoingSandoz Inc
DrugJul 9, 2025
PENICILLIN G POTASSIUM Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units recall — FDA D-0570-2025
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class IFDA: OngoingSandoz Inc
DrugDec 8, 2021
Sandoz Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic recall — FDA D-0286-2022
Temperature Abuse; temperature excursion during shipping
Class IFDA: CompletedSandoz Inc.
DrugMay 13, 2020
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in recall — FDA D-1259-2020
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Class IIFDA: TerminatedSandoz, Inc.
DrugNov 6, 2019
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension recall — FDA D-0162-2020
Labeling: Incorrect or missing package insert.
Class IIIFDA: TerminatedSandoz Inc.
DrugNov 6, 2019
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only recall — FDA D-0163-2020
Labeling: Incorrect or missing package insert.
Class IIIFDA: TerminatedSandoz Inc.
DrugNov 6, 2019
Bimatoprost Ophthalmic Solution 0.03% recall — FDA D-0161-2020
Labeling: Incorrect or missing package insert.
Class IIIFDA: TerminatedSandoz Inc.
DrugDec 5, 2018
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count recall — FDA D-0359-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of…
Class IIFDA: OngoingSandoz, Inc.
DrugApr 25, 2018
Sandoz Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles recall — FDA D-0631-2018
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class IIIFDA: TerminatedSandoz Inc.
DrugOct 4, 2017
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) recall — FDA D-1179-2017
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class IIIFDA: TerminatedSandoz Inc.
DrugMar 1, 2017
Sandoz Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch recall — FDA D-0481-2017
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The…
Class IIFDA: TerminatedSandoz Inc.
DrugJan 25, 2017
Sandoz Donepezil Hydrochloride Tablets, 10 mg recall — FDA D-0435-2017
Subpotent Drug: out of specification results for assay test.
Class IIIFDA: TerminatedSandoz Inc.
DrugNov 23, 2016
Sandoz L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials recall — FDA D-0141-2017
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class IIFDA: TerminatedSandoz Inc.
DrugNov 23, 2016
Sandoz L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose recall — FDA D-0140-2017
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class IIFDA: TerminatedSandoz Inc.
DrugNov 16, 2016
Sandoz Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack recall — FDA D-0133-2017
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Class IIFDA: TerminatedSandoz Inc.
DrugSep 28, 2016
Sandoz Phenylephrine HCI Injection, USP, 10mg/mL recall — FDA D-1514-2016
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class IIFDA: TerminatedSandoz Inc.
DrugSep 28, 2016
Sandoz Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial recall — FDA D-1513-2016
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class IIFDA: TerminatedSandoz Inc.
DrugJun 29, 2016
Sandoz Dicloxacillin Sodium Capsules USP, 500mg recall — FDA D-1046-2016
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class IIIFDA: TerminatedSandoz, Inc.
DrugJun 29, 2016
Sandoz Dicloxacillin Sodium Capsules, USP 250mg recall — FDA D-1045-2016
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Class IIIFDA: TerminatedSandoz, Inc.
DrugFeb 17, 2016
Sandoz Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count recall — FDA D-0659-2016
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Class IIIFDA: TerminatedSandoz Inc.
DrugJun 10, 2015
Sandoz Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) recall — FDA D-1115-2015
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class IIIFDA: TerminatedSandoz, Inc.
DrugDec 10, 2014
Sandoz candesartan cilexetil, tablets, 16 mg, 90-count bottles recall — FDA D-0288-2015
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Class IIIFDA: TerminatedSandoz, Inc.
DrugDec 18, 2013
Bumetanide Tablets USP 0.5 mg recall — FDA D-341-2014
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Class IIIFDA: TerminatedSandoz Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Sandoz, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.