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All product recalls associated with Sandoz Inc.
Total Recalls
225
Past Year
15
Class I (Serious)
77
Most Recent
Oct 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Subpotent; Hydrochlorothiazide at the 9 month time point.
Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil.
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
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
The pH levels of these products are not accurately measured due to the use of outdated buffers and pH levels do not meet process specifications.
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
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.
Presence of Particulate Matter: Found during examination of retention samples.
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.
Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1
Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2.
Undeclared FD&C Colors Yellow #5, Yellow #6, Red #3, Red #40, Blue #1 and Blue #2.
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.
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Some of the cases labeled as blueberry muffins actually contain banana nut muffins, resulting in undeclared tree nuts
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
The recalled product is a wading staff used to assist in wading rivers and streams. These staffs, offered in two sizes (52" & 56"), are sterling silver in color and are identified by Simms item numbers AWS101152 or AWS101156 (UPC numbers 94264-10102 or 94264-10103). The item number and UPC numbers can be found on the product hang tag attached to the staff at time of purchase. Affected wading staffs are visibly identifiable by a silver cable connector.