CLASS II Drug recall · Reported 20 Mar 2024 · FDA Enforcement Report
Telmisartan Tablets, USP 40mg recalled by Micro Labs
Micro Labs is recalling Telmisartan Tablets, USP 40mg, distributed in Puerto Rico, Rhode Island, Tennessee. The recall was initiated on 9 Feb 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0388-2024
- FDA event ID
- 93965
- Recalling firm
- Micro Labs, Verna, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2024
- FDA classified
- 14 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 Feb 2024 | Recall initiated by company | |
| 14 Mar 2024 | Classified by FDA | +34 days |
| 20 Mar 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification for blend uniformity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Puerto Rico, TN, RI
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification for blend uniformity.
Which lots are affected?
Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Where was it sold?
Puerto Rico, TN, RI
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Micro Labs
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobazam Tablets 10mg recalled by Micro LabsClobazam | Micro Labs | Potency & Assay | Nationwide |
Other Telmisartan recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS II | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS I | Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan | Alembic Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled by AVKARE | Avkare | Potency & Assay | AZ, CO |