Sandoz, Inc
Complete recall history across all FDA and CPSC categories — 12 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 (12)
FDA drug safety enforcement actions by Sandoz, Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 21, 2022 | Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... | CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. | Class II |
| Apr 21, 2020 | Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... | Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multi... | Class II |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nit... | Class II |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nit... | Class II |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nit... | Class II |
| Nov 1, 2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamin... | Class II |
| May 2, 2016 | Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for ... | Class III |
| May 2, 2016 | Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufa... | Failed Impurities/Degradation Specifications:Out of specification result for ... | Class III |
| Apr 15, 2015 | Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bli... | Failed Impurities/Degradation Specifications: An out of specification (OOS) r... | Class III |
| Oct 2, 2014 | candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... | Failed Impurities/Degradation Specifications: An Out of Specification (OOS) r... | Class III |
| May 22, 2014 | Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufa... | Presence of Foreign Substance: Presence of stainless steel particles. | Class II |
| Oct 9, 2013 | Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... | Cross contamination with other products: Sandoz is recalling certain lots of ... | 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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