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Class II · ModerateRecall completed

Tacrolimus

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# C2307275; Exp. January 2026
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA foreign manufacturer
Brand nameTACROLIMUS
Generic nameTACROLIMUS
Active ingredient(s)TACROLIMUS
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-526-01
Show the full FDA record
Full product labelTacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionUS Nationwide.
Quantity8,280 bottles
Recall initiated2023-12-15
Report date2024-01-17
Recall completed2024-09-16
Recall numberD-0219-2024
ClassificationClass II
FDA statusTerminated
Origin on filePrinceton NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.