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Sandoz Incorporated

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20123
20137
20143
20172
20181
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FDA Recall Terminated Historical recordClass III

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

by Sandoz Incorporated

Reason
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Published
April 25, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

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 only, Manufactured by Sandoz Inc., Princeton, NJ 08540

by Sandoz Incorporated

Reason
Cross Contamination With Other Product: Imipramine
Published
July 12, 2017
Distribution
Product was distributed throughout the U…

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FDA Recall Terminated Historical recordClass II

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

by Sandoz Incorporated

Reason
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Published
January 4, 2017
Distribution
MS and OH.

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FDA Recall Terminated Historical recordClass III

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

by Sandoz Incorporated

Reason
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Published
December 17, 2014
Distribution
AZ

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FDA Recall Terminated Historical recordClass II

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

by Sandoz Incorporated

Reason
Presence of Foreign Substance; tablets may contain stainless steel metal particulates
Published
August 6, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

by Sandoz Incorporated

Reason
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Published
January 1, 2014
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.

by Sandoz Incorporated

Reason
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Published
October 16, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36

by Sandoz Incorporated

Reason
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
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.

by Sandoz Incorporated

Reason
Presence of Particulate Matter: Found during examination of retention samples.
Published
August 14, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15

by Sandoz Incorporated

Reason
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Published
July 24, 2013
Distribution
Distributed to one consignee in Indiana.…

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FDA Recall Terminated Historical recordClass II

Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)

by Sandoz Incorporated

Reason
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.
Published
June 19, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

by Sandoz Incorporated

Reason
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.
Published
May 1, 2013
Distribution
Nationwide

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This page lists recalls that name Sandoz Incorporated as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.