Telmisartan Tablets recall
FDA recall D-0388-2024 · initiated Feb 9, 2024
Micro Labs Limited recalled Telmisartan Tablets in Feb 2024 — an FDA Class II recall (D-0388-2024) because Failed Stability Specifications: Out of specification for blend uniformity.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications: Out of specification for blend uniformity.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 118,080 bottles
Details
- 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.
- Recalling company
- Micro Labs Ltd
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Puerto Rico, TN, RI
- Initiated
- Feb 9, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Telmisartan Tablets recalled?
- Micro Labs Limited recalled Telmisartan Tablets in Feb 2024 — an FDA Class II recall (D-0388-2024) because Failed Stability Specifications: Out of specification for blend uniformity. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Telmisartan Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0388-2024 was: Failed Stability Specifications: Out of specification for blend uniformity.
- Is a recalled Telmisartan Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Telmisartan Tablets are affected?
- Distributed: Puerto Rico, TN, RI. The recall covers these lots — Lot #s: SFBG024, SFBG025, Exp. 05/31/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0388-2024.