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Class II · ModerateActive recall

Tacrolimus

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

Does this affect you?
Check your lot numberLot # C2106445; Exp. 03/2024
Where it was soldNationwide in the USA
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: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg 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
Brand nameTACROLIMUS
Generic nameTACROLIMUS
Active ingredient(s)TACROLIMUS
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-525-01
Show the full FDA record
Full product labelTacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity4,320 bottles
Recall initiated2023-02-08
Report date2023-03-01
Recall completed—
Recall numberD-0330-2023
ClassificationClass II
FDA statusOngoing
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.