Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Telmisartan Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications: Out of specification for blend uniformity.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
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.
Affected NDC
42571-0227-30
Compare with the code on your package — it is the most precise check available.
Drug: Telmisartan Category: Blood Pressure Medication
- Recalling firm
- Micro Labs Limited
- NDC code
- 42571-227-30
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0388-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Telmisartan recalls
See all
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class III · Low risk
Telmisartan and Hydrochlorothiazide Tablets
Superpotent; Hydrochlorothiazide
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class I · High risk
Telmisartan Tablets
Labeling: Label-mixup
Other recalls by Micro Labs Limited
All 2024 recalls
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
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