Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Policy version 2026-07-21, effective July 21, 2026.
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Based on the official records currently available to Public Health Trace, no recalls naming Sandoz Incorporated are currently shown as ongoing. The 16 records below are historical recall records.
Public Health Trace has 16 recalls naming Sandoz Incorporated as the recalling firm, republished from official FDA and USDA sources.
Recall history - 16 terminated records
Recalls by year
A bar chart of the number of recalls naming this company by year.
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
FDA RecallTerminatedTerminated: July 7, 2014Historical 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
FDA RecallTerminatedTerminated: January 29, 2014Historical 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.
FDA RecallTerminatedTerminated: July 7, 2014Historical 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.
FDA RecallTerminatedTerminated: February 26, 2014Historical 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.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
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.
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