CLASS III Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled by AVKARE
AVKARE is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg, distributed in Arizona, Colorado. The recall was initiated on 3 Apr 2019 and the FDA has classified it as Class III.
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-1122-2019
- FDA event ID
- 82564
- Recalling firm
- AVKARE, Pulaski, TN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Apr 2019
- FDA classified
- 11 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 3 Apr 2019 | Recall initiated by company | |
| 11 Apr 2019 | Classified by FDA | +8 days |
| 17 Apr 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
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
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Where it was distributed
AZ, CO
Questions about this recall
Is Telmisartan and Amlodipine Tablets 80 mg/5 mg recalled?
Yes. AVKARE recalled Telmisartan and Amlodipine Tablets 80 mg/5 mg on 3 Apr 2019. The recall is Class III and its status is Terminated. Recall number D-1122-2019.
Why was it recalled?
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Which lots are affected?
Lots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Where was it sold?
AZ, CO
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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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