Prescription Telmisartan Recalled for Failed Blend Uniformity Specifications
Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed blend uniformity specifications. The affected lots (SFBG024, SFBG025) were distributed in Puerto Rico, Tennessee, and Rhode Island.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving a prescription blood pressure medication with a manufacturing defect (blend uniformity failure) that could result in variable drug doses. Although no illnesses or injuries have been reported, the defect creates a potential risk of treatment failure or adverse effects. Per the rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Micro Labs Limited is recalling 118,080 bottles of Telmisartan 40mg tablets due to failed stability specifications for blend uniformity. The affected lot numbers are SFBG024 and SFBG025, with an expiration date of May 31, 2024. The product was manufactured by Micro Labs Limited in Goa, India, for Micro Labs USA Inc. in Somerset, New Jersey.
The recall was issued because the tablets failed testing for blend uniformity, meaning the active ingredient telmisartan is not evenly distributed within the affected batches. This manufacturing defect could result in some tablets containing inconsistent amounts of the active ingredient compared to the labeled 40mg dose.
The affected tablets were distributed to Puerto Rico, Tennessee, and Rhode Island. Patients currently taking the recalled lot numbers should contact their pharmacy or healthcare provider for guidance on obtaining replacement medication.
The recalled product
- 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.
- Manufacturer
- Micro Labs Limited
- Category
- Drug
- Hazard
- Affected units
- 118,080
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: SFBG024
- SFBG025
- Exp. 05/31/2024
Distribution
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