Class II · Moderate risk
Telmisartan Tablets
Failed Stability Specifications: Out of specification for blend uniformity.
Telmisartan Tablets
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label-mixup
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30
Affected NDC
62332-0087-30
Compare with the code on your package — it is the most precise check available.
Drug: Telmisartan Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Telmisartan NDC 62332-0087 |
20 mg/1 | Tablet Oral |
Alembic Pharmaceuticals Inc. | Rx |
- Recalling firm
- Alembic Pharmaceuticals Limited
- NDC code
- 62332-087-30
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0326-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 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
Other recalls by Alembic Pharmaceuticals Limited
All 2021 recalls
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.07%
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class II · Moderate risk
Doxepin Hydrochloride Capsules
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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