CLASS II Drug recall · Reported 12 Feb 2020 · FDA Enforcement Report
Olmesartan Medoxomil Tablets 20 mg recalled by Ascend Laboratories
Ascend Laboratories is recalling Olmesartan Medoxomil Tablets 20 mg, distributed nationwide in the US. The recall was initiated on 24 Jan 2020 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-0828-2020
- FDA event ID
- 84818
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Olmesartan Medoxomil
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2020
- FDA classified
- 6 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 24 Jan 2020 | Recall initiated by company | |
| 6 Feb 2020 | Classified by FDA | +13 days |
| 12 Feb 2020 | 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
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Product as listed by the FDA
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Which lots are affected?
Lot #: 19122552, Exp 7/31/2021
Where was it sold?
Nationwide in the U.S.
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.
More recalls from Ascend Laboratories
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
Other Olmesartan Medoxomil recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Olmesartan Medoxomil Tablets, USP, 20 mg recalled by Ascend LaboratoriesOlmesartan Medoxomil | Ascend Laboratories | Other | Nationwide |
| Drug | CLASS II | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |