Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg,… was recalled on October 1, 2026 in cooperation with the U.S. Food and Drug Administration because superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications.
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.
Lot # 3228113, 3228114, 3228115, Exp Date: Oct 31, 2026; Lot # 3228120, 3228121, Exp Date: Nov 30, 2026.
Units affected: 21,620 30-count bottles
Where it was sold: Nationwide in the USA.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Viatris, Inc.
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
View official notice →The recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottle is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are ingested by young children.
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Lack of sterility assurance.
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