Tacrolimus Capsules (Sandoz) – Product Contamination (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Sandoz Incorporated
Lot Codes / Batch Numbers
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Products Sold
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Sandoz Incorporated is recalling Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Priv due to Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026