Micardis (Telmisartan) 80 mg Tablets Recall Due to Subpotency
Boehringer Ingelheim Pharmaceuticals is recalling Micardis 80 mg tablets (Lot #860412, expiration September 2022) because the tablets contain less active ingredient than required. This is a voluntary Class II recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall that is voluntary and precautionary in nature. The hazard is subpotency (reduced active ingredient), which does not match the criteria for higher severity (no reported illnesses, hospitalizations, or high-risk pathogens). It falls under the "minor labeling/potency errors, voluntary precautionary recalls" category typical of severity 2.
Plain-English summary
Boehringer Ingelheim Pharmaceuticals, Inc., located in Ridgefield, CT, is voluntarily recalling 15,198 bottles of Micardis (telmisartan) 80 mg tablets due to subpotency. The affected lot is #860412 with an expiration date of September 2022. The tablets contain less active pharmaceutical ingredient than specified on the label.
The affected product was distributed to Arkansas, Colorado, Connecticut, Louisiana, North Carolina, North Dakota, New Hampshire, New Jersey, Ohio, Pennsylvania, and Puerto Rico.
Patients taking this medication should contact their healthcare provider or pharmacist immediately. Do not stop taking the medication without speaking to a healthcare professional, as abruptly stopping an angiotensin II receptor blocker can have health consequences. The medication should be returned to the pharmacy or disposed of according to local pharmaceutical disposal guidelines.
The recalled product
- Product
- MICARDIS (TELMISARTAN)
- Brand
- MICARDIS
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Hazard
- subpotency
- insufficient-active-ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #860412
- SEPT 2022
Distribution
Distributed in 11 states:
- AR
- CO
- CT
- LA
- NC
- ND
- NH
- NJ
- OH
- PA
- PR
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