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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
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
Related recalls
Same manufacturer · Boehringer Ingelheim Pharmaceuticals, Inc.
See all →- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- HighPrescription Drug Recall: Jardiance Empagliflozin 25 mg Label Mix-Up
FDA (Drugs) · 2023-03-29
- ModerateBoehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
FDA (Drugs) · 2020-11-04
- ModerateBoehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
FDA (Drugs) · 2020-11-04
- ModerateBoehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Testing Anomaly
FDA (Drugs) · 2020-11-04
Same hazard · subpotency
See all →- SeverePfizer Recalls Subpotent Levoxyl Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-10-28
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
Similar recalls
- LowBoehringer Ingelheim Recalls Mirapex Tablets Due to Low Weight
FDA (Drugs) · 2019-03-20
- ModerateBoehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets
FDA (Drugs) · 2015-06-03
- ModerateOxcarbazepine Tablets Recalled for Potential Subpotency
FDA (Drugs) · 2013-12-18
- LowMylan Recalls Subpotent Triamterene and Hydrochlorothiazide Tablets Nationwide
FDA (Drugs) · 2018-07-18
- ModerateViatris Recalls Telmisartan and Amlodipine Tablets Due to Superpotent Drug Risk
FDA (Drugs) · 2026-10-28
- ModerateTelmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency
FDA (Drugs) · 2021-12-22