Sandoz recalls
Sandoz appears in 61 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 61 |
|---|---|
| Published | 2012-09-26 to 2026-06-24 |
| By agency | FDA Drug (59), CPSC (2) |
| By classification | Class II (28), Class III (27), Class I (4) |
| By status | terminated (52), ongoing (6), completed (1) |
| Distribution named in notices | AZ, CA, IN, MS, NY, OH, PR, TN, US, VA, WI |
Recalls
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC,…
FDA Drug · Class III · 2026-06-24 · Sandoz
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fa…
FDA Drug · Class II · 2025-09-24 · Sandoz
Reason: cGMP deviations: Temperature excursion during transportation. - Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgiu…
FDA Drug · Class II · 2025-09-17 · Sandoz
Reason: Temperature Abuse - Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sand…
FDA Drug · Class I · 2025-07-09 · Sandoz
Reason: 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 Cefozalin - Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austr…
FDA Drug · Class I · 2025-07-09 · Sandoz
Reason: 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 - Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-…
FDA Drug · Class II · 2022-04-13 · Sandoz
Reason: CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. - Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only
FDA Drug · Class I · 2021-12-08 · Sandoz
Reason: Temperature Abuse; temperature excursion during shipping - Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthca…
FDA Drug · Class II · 2020-05-13 · Sandoz
Reason: Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins - Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc
FDA Drug · Class III · 2019-11-06 · Sandoz
Reason: Labeling: Incorrect or missing package insert. - Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5…
FDA Drug · Class III · 2019-11-06 · Sandoz
Reason: Labeling: Incorrect or missing package insert. - Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratorie…
FDA Drug · Class III · 2019-11-06 · Sandoz
Reason: Labeling: Incorrect or missing package insert. - Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz
Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). - Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz
Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). - Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc
FDA Drug · Class II · 2019-10-16 · Sandoz
Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). - Losartan Potassium and Ezetimibe prescription drug bottles
CPSC · 2019-08-29 · Sandoz
Reason: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children. - Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufacture…
FDA Drug · Class II · 2018-12-05 · Sandoz
Reason: 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 0.083 parts per million. - Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, T…
FDA Drug · Class III · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01)
FDA Drug · Class III · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laborato…
FDA Drug · Class II · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc
FDA Drug · Class II · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laborato…
FDA Drug · Class II · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laborator…
FDA Drug · Class II · 2018-11-21 · Sandoz
Reason: Cross Contamination with Other Products - Blister packages of prescription medication
CPSC · 2018-07-06 · Sandoz
Reason: The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children. - Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 0854…
FDA Drug · Class III · 2018-04-25 · Sandoz
Reason: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous). - Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), R…
FDA Drug · Class III · 2017-10-04 · Sandoz
Reason: Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels. - Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx…
FDA Drug · Class III · 2017-07-12 · Sandoz
Reason: Cross Contamination With Other Product: Imipramine - Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for…
FDA Drug · Class III · 2017-06-07 · Sandoz
Reason: Subpotent Drug; Clavulanic Acid - Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulic…
FDA Drug · Class II · 2017-03-15 · Sandoz
Reason: Failed Dissolution Specifications - Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC…
FDA Drug · Class II · 2017-03-01 · Sandoz
Reason: 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 pouch containing the patch is l… - Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx…
FDA Drug · Class III · 2017-01-25 · Sandoz
Reason: Subpotent Drug: out of specification results for assay test. - Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
FDA Drug · Class II · 2017-01-04 · Sandoz
Reason: Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%) - Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwid…
FDA Drug · Class III · 2016-11-30 · Sandoz
Reason: Labeling: Missing Label - L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per…
FDA Drug · Class II · 2016-11-23 · Sandoz
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. - L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per ca…
FDA Drug · Class II · 2016-11-23 · Sandoz
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised. - Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfi…
FDA Drug · Class II · 2016-11-16 · Sandoz
Reason: Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application. - Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-0…
FDA Drug · Class II · 2016-09-28 · Sandoz
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. - Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-0…
FDA Drug · Class II · 2016-09-28 · Sandoz
Reason: Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised. - Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc.,…
FDA Drug · Class III · 2016-06-29 · Sandoz
Reason: Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. - Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. ,…
FDA Drug · Class III · 2016-06-29 · Sandoz
Reason: Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing. - Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
FDA Drug · Class III · 2016-06-22 · Sandoz
Reason: Labeling: Incorrect or Missing Package Insert - Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by…
FDA Drug · Class III · 2016-02-17 · Sandoz
Reason: Failed Impurities/Degradation Specifications; 9 month stability timepoint - Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations
FDA Drug · Class III · 2015-06-10 · Sandoz
Reason: Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point. - Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
FDA Drug · Class III · 2014-12-17 · Sandoz
Reason: Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule. - candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories L…
FDA Drug · Class III · 2014-12-10 · Sandoz
Reason: 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. - Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
FDA Drug · Class II · 2014-08-06 · Sandoz
Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates - Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx o…
FDA Drug · Class III · 2014-07-30 · Sandoz
Reason: Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. - Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only
FDA Drug · Class II · 2014-06-04 · Sandoz
Reason: Presence of Foreign Substance: Presence of stainless steel particles. - Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc
FDA Drug · Class II · 2014-01-08 · Sandoz
Reason: Subpotent; Hydrochlorothiazide at the 9 month time point. - Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ…
FDA Drug · Class II · 2014-01-01 · Sandoz
Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin - Bumetanide Tablets USP 0.5 mg
FDA Drug · Class III · 2013-12-18 · Sandoz
Reason: 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.