Sandoz Inc
Complete recall history across all FDA and CPSC categories — 30 total recalls
Sandoz Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (30)
FDA drug safety enforcement actions by Sandoz Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 5, 2025 | Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... | cGMP deviations: Temperature excursion during transportation. | Class II |
| Aug 13, 2025 | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in... | Temperature Abuse | Class II |
| Jun 27, 2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram wer... | Class I |
| Jun 27, 2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were f... | Class I |
| Nov 17, 2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... | Temperature Abuse; temperature excursion during shipping | Class I |
| Oct 17, 2019 | Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... | Labeling: Incorrect or missing package insert. | Class III |
| Oct 17, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... | Labeling: Incorrect or missing package insert. | Class III |
| Oct 17, 2019 | Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... | Labeling: Incorrect or missing package insert. | Class III |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... | Cross Contamination with Other Products | Class II |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... | Cross Contamination with Other Products | Class II |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... | Cross Contamination with Other Products | Class III |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... | Cross Contamination with Other Products | Class III |
| Sep 25, 2017 | Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78... | Labeling: Missing Label: customer complaint that some vials of ampicillin wit... | Class III |
| Apr 26, 2017 | Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... | Subpotent Drug; Clavulanic Acid | Class III |
| Feb 10, 2017 | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o... | Failed Dissolution Specifications | Class II |
| Feb 2, 2017 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N... | Labeling: Incorrect Instructions:outer carton contains the incorrect instruct... | Class II |
| Dec 13, 2016 | Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC ... | Subpotent Drug: out of specification results for assay test. | Class III |
| Nov 9, 2016 | L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing ... | Class II |
| Nov 9, 2016 | L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing ... | Class II |
| Oct 19, 2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... | Labeling: Missing Label | Class III |
| Aug 24, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing ... | Class II |
| Aug 24, 2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing ... | Class II |
| Aug 24, 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... | Defective Delivery System; reports of damaged product that may alter the pred... | Class II |
| May 25, 2016 | Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... | Labeling: Incorrect or Missing Package Insert | Class III |
| Dec 31, 2015 | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... | Failed Impurities/Degradation Specifications; 9 month stability timepoint | Class III |
| Jul 11, 2014 | Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... | Failed Dissolution Specifications: Product found to be out of specification (... | Class III |
| Nov 6, 2013 | Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bot... | Failed Moisture Limit; Out of Specification (OOS) results were obtained for m... | Class III |
| Oct 11, 2013 | Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 10... | Subpotent; Hydrochlorothiazide at the 9 month time point. | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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