Sandoz Inc recalls

47 recalls in our records from 2012 to 2026: 45 FDA drugs, 2 CPSC.

Recalls with full detail pages

• FDA · DrugsClass IJul 9, 2025

  Sandoz Inc drug recall: Cefazolin for Injection

  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.…

Earlier and other recalls

These link to the official agency notice.

• FDA · DrugsClass IIIJun 24, 2026

  Sandoz Inc drug recall: Focalin XR Official notice ↗

  Labeling: Incorrect or Missing Lot and/or Exp Date

• FDA · DrugsClass IISep 24, 2025

  Sandoz Inc drug recall: Cyclophosphamide Injection 500 mg/5 mL Official notice ↗

  cGMP deviations: Temperature excursion during transportation.

• FDA · DrugsClass IISep 17, 2025

  Sandoz Inc drug recall: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only Official notice ↗

  Temperature Abuse

• CPSC · Consumer productMar 9, 2023

  Sandoz Recalls Aprepitant Capsules and Lidocaine and Prilocaine Cream Prescription Drugs Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning Official notice ↗

  The recalled prescription drugs and products that contain lidocaine must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The…

• FDA · DrugsClass IIApr 13, 2022

  Sandoz, Inc drug recall: Orphenadrine Citrate Extended-Release Tablets Official notice ↗

  CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

• FDA · DrugsClass IDec 8, 2021

  Sandoz Inc drug recall: Enoxaparin Sodium Injection Official notice ↗

  Temperature Abuse; temperature excursion during shipping

• FDA · DrugsClass IIMay 13, 2020

  Sandoz, Inc drug recall: Infuvite PEDiatric Pharmacy Official notice ↗

  Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

• FDA · DrugsClass IIINov 6, 2019

  Sandoz Inc drug recall: Bimatoprost Ophthalmic Solution 0.03% Official notice ↗

  Labeling: Incorrect or missing package insert.

• FDA · DrugsClass IIOct 16, 2019

  Sandoz, Inc drug recall: Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only… Official notice ↗

  CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

• CPSC · Consumer productAug 29, 2019

  Sandoz Recalls Losartan Potassium and Ezetimibe Prescription Drug Bottles Due to Failure to Meet Child-Resistant Closure Requirements Official notice ↗

  The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.

• FDA · DrugsClass IIDec 5, 2018

  Sandoz, Inc drug recall: Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Official notice ↗

  CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable…

• FDA · DrugsClass IIClass IIINov 21, 2018

  Sandoz Inc drug recall: Nitrofurantoin Capsules Official notice ↗

  Cross Contamination with Other Products

• FDA · DrugsClass IIIApr 25, 2018

  Sandoz Incorporated drug recall: Triamterene and Hydrochlorothiazide Tablets Official notice ↗

  Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

• FDA · DrugsClass IIIOct 4, 2017

  Sandoz Inc drug recall: Ampicillin for Injection Official notice ↗

  Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

• FDA · DrugsClass IIIJul 12, 2017

  Sandoz Incorporated drug recall: Amitriptyline HCl Tablets Official notice ↗

  Cross Contamination With Other Product: Imipramine

• FDA · DrugsClass IIIJun 7, 2017

  Sandoz Inc drug recall: Amoxicillin and Clavulanate Potassium Tablets Official notice ↗

  Subpotent Drug; Clavulanic Acid

• FDA · DrugsClass IIMar 15, 2017

  Sandoz Inc drug recall: Pioglitazone and Glimepiride Tablets Official notice ↗

  Failed Dissolution Specifications

• FDA · DrugsClass IIMar 1, 2017

  Sandoz Inc drug recall: Transderm Scop Official notice ↗

  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…

• FDA · DrugsClass IIIJan 25, 2017

  Sandoz Inc drug recall: Donepezil Hydrochloride Tablets Official notice ↗

  Subpotent Drug: out of specification results for assay test.

• FDA · DrugsClass IIJan 4, 2017

  Sandoz Incorporated drug recall: Nadolol Tablets Official notice ↗

  Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

• FDA · DrugsClass IIINov 30, 2016

  Sandoz Inc drug recall: Ceftriaxone for Injection Official notice ↗

  Labeling: Missing Label

• FDA · DrugsClass IINov 23, 2016

  Sandoz Inc drug recall: L-Cysteine Hydrochloride Injection Official notice ↗

  Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.

• FDA · DrugsClass IINov 16, 2016

  Sandoz Inc drug recall: Transderm Scop Official notice ↗

  Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.

• FDA · DrugsClass IISep 28, 2016

  Sandoz Inc drug recall: Ephedrine Sulfate Injection Official notice ↗

  Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.

• FDA · DrugsClass IIIJun 29, 2016

  Sandoz, Inc drug recall: Dicloxacillin Sodium Capsules Official notice ↗

  Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.

• FDA · DrugsClass IIIJun 22, 2016

  Sandoz Inc drug recall: Lisinopril Tablets USP Official notice ↗

  Labeling: Incorrect or Missing Package Insert

• FDA · DrugsClass IIIFeb 17, 2016

  Sandoz Inc drug recall: Candesartan Cilexetil Tablets Official notice ↗

  Failed Impurities/Degradation Specifications; 9 month stability timepoint

• FDA · DrugsClass IIIJun 10, 2015

  Sandoz, Inc drug recall: Cetirizine HCl Chewable Tablet Official notice ↗

  Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

• FDA · DrugsClass IIIDec 17, 2014

  Sandoz Incorporated drug recall: Fluoxetine Capsules USP Official notice ↗

  Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

• FDA · DrugsClass IIIDec 10, 2014

  Sandoz, Inc drug recall: candesartan cilexetil Official notice ↗

  Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and…

• FDA · DrugsClass IIAug 6, 2014

  Sandoz Incorporated drug recall: Alprazolam Tablets Official notice ↗

  Presence of Foreign Substance; tablets may contain stainless steel metal particulates

• FDA · DrugsClass IIIJul 30, 2014

  Sandoz Inc drug recall: Orphenadrine Citrate Extended Release Tablets Official notice ↗

  Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

• FDA · DrugsClass IIJun 4, 2014

  Sandoz, Inc drug recall: Cefpodoxime Proxetil Tablets Official notice ↗

  Presence of Foreign Substance: Presence of stainless steel particles.

• FDA · DrugsClass IIJan 8, 2014

  Sandoz Inc drug recall: Fosinopril Sodium and Hydrochlorothiazide Tablets Official notice ↗

  Subpotent; Hydrochlorothiazide at the 9 month time point.

• FDA · DrugsClass IIJan 1, 2014

  Sandoz Incorporated drug recall: Tacrolimus Capsules Official notice ↗

  Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

• FDA · DrugsClass IIIDec 18, 2013

  Sandoz Inc drug recall: Bumetanide Tablets USP 0.5 mg. Rx Only Official notice ↗

  Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room…

• FDA · DrugsClass IINov 13, 2013

  Sandoz, Inc drug recall: Ropinirole Official notice ↗

  Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming…

• FDA · DrugsClass IIIOct 16, 2013

  Sandoz Incorporated drug recall: Hydroxychloroquine Sulfate Tablets Official notice ↗

  Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.

• FDA · DrugsClass IIIAug 14, 2013

  Sandoz Incorporated drug recall: Introvale Official notice ↗

  Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily…

• FDA · DrugsClass IAug 14, 2013

  Sandoz Incorporated drug recall: Methotrexate Injection Official notice ↗

  Presence of Particulate Matter: Found during examination of retention samples.

• FDA · DrugsClass IIJul 24, 2013

  Sandoz Incorporated drug recall: Estarylla Official notice ↗

  Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.

• FDA · DrugsClass IIJun 19, 2013

  Sandoz Incorporated drug recall: Cefazolin Official notice ↗

  Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which…

• FDA · DrugsClass IIMay 1, 2013

  Sandoz Incorporated drug recall: Amoxicillin Capsules USP 500 mg Official notice ↗

  Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire…

• FDA · DrugsClass IIIFeb 13, 2013

  Sandoz Incorporated drug recall: Syeda Official notice ↗

  Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

• FDA · DrugsClass IIIOct 24, 2012

  Sandoz Incorporated drug recall: Children's Cetirizine HCl Chewable Tablets 5 mg Official notice ↗

  Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

• FDA · DrugsClass IIISep 26, 2012

  Sandoz Incorporated drug recall: Pramipexole Dihydrochloride Tablets Official notice ↗

  Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.