CLASS III Drug recall · Reported 2 Jun 2021 · FDA Enforcement Report
Olmesartan Medoxomil Tablets, USP, 20 mg recalled by Ascend Laboratories
Ascend Laboratories is recalling Olmesartan Medoxomil Tablets, USP, 20 mg, distributed nationwide in the US. The recall was initiated on 29 Apr 2021 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-0392-2021
- FDA event ID
- 87817
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Olmesartan Medoxomil
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Apr 2021
- FDA classified
- 24 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 29 Apr 2021 | Recall initiated by company | |
| 24 May 2021 | Classified by FDA | +25 days |
| 2 Jun 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet/Capsule
Product as listed by the FDA
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablet/Capsule
Which lots are affected?
Batch No. 20122548, Exp Date: Aug. 2022
Where was it sold?
Nationwide
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 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 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
Other Olmesartan Medoxomil recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olmesartan Medoxomil Tablets 20 mg recalled by Ascend LaboratoriesOlmesartan Medoxomil | Ascend Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |