CLASS II Drug recall · Reported 9 Jun 2021 · FDA Enforcement Report
Micardis Tablets, (telmisartan Tablets) 80 mg per folding recalled
Boehringer Ingelheim Pharmaceuticals is recalling Micardis Tablets, (telmisartan Tablets) 80 mg per folding, distributed in 11 states. The recall was initiated on 4 May 2021 and the FDA has classified it as Class II.
Check your package
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-0600-2021
- FDA event ID
- 87856
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 May 2021
- FDA classified
- 28 May 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 4 May 2021 | Recall initiated by company | |
| 28 May 2021 | Classified by FDA | +24 days |
| 9 Jun 2021 | 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
Subpotent Drug
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
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
Where it was distributed
AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
ArkansasColoradoConnecticutLouisianaNorth CarolinaNorth DakotaNew HampshireNew JerseyOhioPennsylvaniaPuerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #860412; SEPT 2022
Where was it sold?
AR, CO, CT, LA, NC, ND, NH, NJ, OH, PA and PR
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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