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Verified · FDAClass III — Low RiskMedications

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only Recall 2026

TELMISARTAN AND AMLODIPINEIssued October 1, 2026Updated Reviewed by the Recall Watch editorial team

TELMISARTAN AND AMLODIPINE Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93. — recalled per FDA on 10/1/2026. Reason: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.

Agency
FDA
Issued
Oct 1, 2026
Brand
TELMISARTAN AND AMLODIPINE
Distribution
1 states
Lots affected
9
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued October 1, 2026 · Last synced Nov 2, 2026

What's recalled

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.

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Why it was recalled

Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

Affected products & lot numbers
9 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot # 3228113
3228114
3228115
Exp Date: Oct 31
2026
Lot # 3228120
3228121
Exp Date: Nov 30
2026.
Where was it sold
1 state

Nationwide in the USA.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the TELMISARTAN AND AMLODIPINE recall still active?

Yes, this recall is currently active as of October 1, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026, Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.. Check the label on your product.

What should I do if I have the recalled TELMISARTAN AND AMLODIPINE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.