Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Tacrolimus Capsules Recalled by Sandoz Incorporated Due to Cross Contamination with Other Products: findings of carryover...

Date: October 22, 2013
Company: Sandoz Incorporated
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Incorporated directly.

Affected Products

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

Quantity: 12,521 bottles

Why Was This Recalled?

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sandoz Incorporated

Sandoz Incorporated has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report