Tacrolimus Capsule
FDA Recall NDC 55111-526
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tacrolimus (NDC 55111-526). A significant event, classified as Class II, was initiated on Dec 15, 2023 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Dec 15, 2023
Jan 17, 2024
8,280 bottles
Recall Profile & Regulatory Data
Event ID
93622
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Termination Date
Sep 16, 2024
Product Description
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
Batch or Lot Expiration Information
Lot# C2307275; Exp. January 2026
Affected Packages Involved in this Recall
55111-525-30Product
55111-525-01Product
55111-525-05Product
55111-525-79Product
55111-525-78Product
55111-526-30Product
55111-526-01Product
55111-526-05Product
55111-526-79Product
55111-526-78Product
55111-527-30Product
55111-527-01Product
55111-527-05Product
55111-527-79Product
55111-527-78Product
Class II Ongoing
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.
Feb 08, 2023
Mar 01, 2023
4,320 bottles
Recall Profile & Regulatory Data
Event ID
91661
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product 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.
Batch or Lot Expiration Information
Lot# C2106445; Exp. 03/2024
Affected Packages Involved in this Recall
55111-525-30Product
55111-525-01Product
55111-525-05Product
55111-525-79Product
55111-525-78Product
55111-526-30Product
55111-526-01Product
55111-526-05Product
55111-526-79Product
55111-526-78Product
55111-527-30Product
55111-527-01Product
55111-527-05Product
55111-527-79Product
55111-527-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
