Product Safety Recalls

Product Recall Tracker

TACROLIMUS Recall D-0330-2023

Description: Tacrolimus 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.

TACROLIMUS Recall D-0330-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0330-2023
Event ID91661
Original Package?1
Active SubstanceTACROLIMUS
Drug RouteORAL
DistributionNationwide in the USA
Quantity4,320 bottles
Recall ReasonPresence 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.
Drug ClassificationClass II
Drug Code Info20230301
Product NDC55111-525 55111-526 55111-527
Drug UPC0355111526018 0355111525011 0355111527015
Recall Initiation Date20230208
Report Date20230301
Classification Date20230221
Address107 College Rd E
Princeton, NJ 08540-6623
United States
Recalling FirmDr. Reddy's Laboratories, Inc.
Initial Notification Letter
Unique Ingredient IdentifierWM0HAQ4WNM
Drug Application NumberANDA090509
Structured Product Labeling (SPL ID)1f9cc1ab-687d-eb66-9b7f-867cca0600fb
Structured Product Labeling (SPL Set ID)61dee012-43af-0e9a-3843-9b9b91e022c4
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.