February 2024 FDA Recall Telmisartan by Micro Labs Limited
D-0388-2024 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Micro Labs Limited on February 9, 2024 for the product Telmisartan. The FDA reported the reason for recall as failed stability specifications. The product was distributed in Puerto Rico, TN, RI and the recall is currently terminated.
Recall Number: D-0388-2024
Failed Stability Specifications: Out of specification for blend uniformity.
02-09-2024
03-20-2024
118,080 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Micro Labs Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Puerto Rico, TN, RI
06-24-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
