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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

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

by Sandoz Incorporated

Reason
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.
Published
February 13, 2013
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33

by Sandoz Incorporated

Reason
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Published
October 24, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92

by Sandoz Incorporated

Reason
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Published
September 26, 2012
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,

by Sandoz Incorporated

Reason
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Published
September 26, 2012
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.