Recall archive / FDA drug enforcement
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA... — FDA record D-0388-2024
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Micro Labs Limited
- Quantity
- 118,080 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0388-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #s: SFBG024, SFBG025, Exp. 05/31/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Puerto Rico, TN, RI
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 20, 2024
- Recall initiation date
- Feb 9, 2024
- Center classification date
- Mar 14, 2024
- Termination date
- Jun 24, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.