Telmisartan Tablet
FDA Recall NDC 42571-227
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Telmisartan (NDC 42571-227). A significant event, classified as Class II, was initiated on Feb 09, 2024 by Micro Labs Limited. The reported reason for this action was: "Failed Stability Specifications: Out of specification for blend uniformity."
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
Failed Stability Specifications: Out of specification for blend uniformity.
Feb 09, 2024
Mar 20, 2024
118,080 bottles
Recall Profile & Regulatory Data
Event ID
93965
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Micro Labs Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Puerto Rico, TN, RI
Termination Date
Jun 24, 2025
Product Description
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Batch or Lot Expiration Information
Lot# s: SFBG024, SFBG025, Exp. 05/31/2024
Affected Packages Involved in this Recall
42571-226-30Product
42571-226-90Product
42571-226-05Product
42571-226-10Product
42571-226-32Product
42571-226-11Product
42571-226-41Product
42571-227-30Product
42571-227-90Product
42571-227-05Product
42571-227-10Product
42571-227-32Product
42571-227-11Product
42571-227-41Product
42571-228-30Product
42571-228-90Product
42571-228-05Product
42571-228-10Product
42571-228-32Product
42571-228-11Product
42571-228-41Product
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.
