FDA recall, , Low risk
Mylan Telmisartan and Amlodipine Tablets
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.
Summary by Recall Canary from the FDA notice
What happened
Viatris, Inc. recalled Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, manufactured for Mylan Pharmaceuticals Inc., due to a superpotent drug potential for the Telmisartan content in these lots to exceed specifications. The recall began on October 1, 2026, and was added to the FDA's Enforcement Report on October 16, 2026. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 0378-1075-93
- Lot code
- 3228113
- 3228114
- 3228115
- 3228120
- 3228121
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Viatris, Inc.
- Hazard
- Wrong drug strength
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 100048
- Recall number
- D-0049-2027
All recalls from Viatris, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
