Sandoz Incorporated
Complete recall history across all FDA and CPSC categories — 16 total recalls
Sandoz Incorporated 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 (16)
FDA drug safety enforcement actions by Sandoz Incorporated
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 6, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... | Cross Contamination With Other Products: presence of unrelated ingredients (i... | Class III |
| Jun 16, 2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... | Cross Contamination With Other Product: Imipramine | Class III |
| Dec 22, 2016 | Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... | Failed dissolution specification: recalled due to an out of specification dis... | Class II |
| Dec 5, 2014 | Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... | Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine ... | Class III |
| Jul 25, 2014 | Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeto... | Presence of Foreign Substance; tablets may contain stainless steel metal part... | Class II |
| Oct 22, 2013 | Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: findings of carryover of trace amoun... | Class II |
| Sep 25, 2013 | Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bot... | Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxyc... | Class III |
| Aug 7, 2013 | Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 m... | Contraceptive tablets out of sequence: Contraceptive tablets out of sequence:... | Class III |
| Jun 21, 2013 | Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, ... | Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of... | Class II |
| May 30, 2013 | Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, si... | Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injecti... | Class II |
| May 20, 2013 | Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL S... | Presence of Particulate Matter: Found during examination of retention samples. | Class I |
| Apr 18, 2013 | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for S... | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicilli... | Class II |
| Jan 22, 2013 | Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blist... | Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contai... | Class III |
| Sep 20, 2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manuf... | Impurity/Degradation; exceeded impurity specification at the 8 and 15 month t... | Class III |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx... | Impurities/Degradation Products: An out of specification result for a known i... | Class III |
| Sep 12, 2012 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, R... | Impurities/Degradation Products: An out of specification result for a known i... | Class III |
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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