RecallRadar

FDA Drug recall D-0388-2024

Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Mi…

On 2024-03-20 the FDA classified a Class II recall of Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Mi… by Micro Labs, citing failed Stability Specifications: Out of specification for blend uniformity.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0388-2024
ClassificationClass II
Statusterminated
Initiated2024-02-09
Published2024-03-20
Last updated2026-09-13 11:52 UTC
CompanyMicro Labs
DistributionPR, RI, TN

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.

Reason

Failed Stability Specifications: Out of specification for blend uniformity.

Identifiers

code_infoLot #s: SFBG024, SFBG025, Exp. 05/31/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0388-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.