CLASS III ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg recalled by Viatris

Viatris is recalling Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, distributed nationwide in the US. The recall was initiated on 1 Oct 2026 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.

NDC0378-1075, 0378-1076, 0378-1077, 0378-1078

UPC0303781075930, 0303781076937, 0303781078931, 0303781077934

Quantity recalled21,620 30-count bottles

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-0049-2027
FDA event ID: 100048
Recalling firm: Viatris, Morgantown, WV
Brand: Telmisartan And Amlodipine
Manufacturer: Mylan Pharmaceuticals Inc.
Classification: Class III
Status: Ongoing
Recall initiated: 1 Oct 2026
FDA classified: 16 Oct 2026
Reported: 28 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

1 Oct 2026	Recall initiated by company
16 Oct 2026	Classified by FDA	+15 days
28 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

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 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.

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.

Where was it sold?

Nationwide in the USA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 3 Nov 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 Viatris

All 26

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15 Apr 2026Drug	CLASS II	Xanax XR, alprazolam, extended-release tablets, 3 mg recalled by Viatris	Viatris	Potency & Assay	Nationwide
22 Jan 2025Drug	CLASS II	Cardura XL (doxazosin) extended release tablets 4 mg recalled by ViatrisCardura	Viatris	Potency & Assay	Nationwide
22 Jan 2025Drug	CLASS II	Cardura XL (doxazosin) extended release tablets 8 mg recalled by ViatrisCardura	Viatris	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets USP, 25 mcg recalled by Viatris	Viatris	Potency & Assay	Nationwide
18 Dec 2024Drug	CLASS II	Levothyroxine Sodium Tablets USP, 75 mcg recalled by Viatris	Viatris	Potency & Assay	Nationwide

Other Telmisartan recalls

All 12

Reported	Class	Recall	Company	Reason	Where
20 Mar 2024Drug	CLASS II	Telmisartan Tablets, USP 40mg recalled by Micro Labs	Micro Labs	Potency & Assay	PR, RI, TN
17 Aug 2022Drug	CLASS II	Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg recalledTelmisartan And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
17 Aug 2022Drug	CLASS II	Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg recalledTelmisartan And Hydrochlorothiazide	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
22 Dec 2021Drug	CLASS III	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled	Torrent Pharma	Potency & Assay	Nationwide
14 Apr 2021Drug	CLASS I	Telmisartan Tablets, USP 20 mg recalled by Alembic PharmaceuticalsTelmisartan	Alembic Pharmaceuticals	Packaging Defects	Nationwide