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Sandoz Incorporated Recalls
16 recalls on record · September 26, 2012 to April 25, 2018 · Drugs
Recalls by year
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18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
April 25, 2018DrugsFDA
Sandoz Incorporated recalls Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc.,
Hazard: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
July 12, 2017DrugsFDA
Sandoz Incorporated recalls Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC
Hazard: Cross Contamination With Other Product: Imipramine
January 4, 2017DrugsFDA
Sandoz Incorporated recalls Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, N
Hazard: Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
December 17, 2014DrugsFDA
Sandoz Incorporated recalls Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Hazard: Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
August 6, 2014DrugsFDA
Sandoz Incorporated recalls Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10
Hazard: Presence of Foreign Substance; tablets may contain stainless steel metal particulates
January 1, 2014DrugsFDA
Sandoz Incorporated recalls Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz
Hazard: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
October 16, 2013DrugsFDA
Sandoz Incorporated recalls Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC
Hazard: Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
August 14, 2013DrugsFDA
Sandoz Incorporated recalls Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit cart
Hazard: Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
August 14, 2013DrugsFDA
Sandoz Incorporated recalls Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for:
Hazard: Presence of Particulate Matter: Found during examination of retention samples.
July 24, 2013DrugsFDA
Sandoz Incorporated recalls Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufac
Hazard: Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
June 19, 2013DrugsFDA
Sandoz Incorporated recalls Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by S
Hazard: 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 was confirmed through review of retained samples.
May 1, 2013DrugsFDA
Sandoz Incorporated recalls Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only.
Hazard: 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 mesh.
February 13, 2013DrugsFDA
Sandoz Incorporated recalls Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tab
Hazard: 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.
October 24, 2012DrugsFDA
Sandoz Incorporated recalls Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., fo
Hazard: Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
September 26, 2012DrugsFDA
Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Pri
Hazard: Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
September 26, 2012DrugsFDA
Sandoz Incorporated recalls Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Priv
Hazard: Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.