Quick Facts at a Glance
- Recall Date
- July 8, 2026
- Hazard Level
- HIGH
- Brands
- AMLODIPINE AND OLMESARTAN MEDOXOMIL, Ascend Laboratories, LLC
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL, Ascend Laboratories, LLC
- Model numbers
- Lot 25121311, expiry 3/31/2028
- UPC codes
- 67877-499, 67877-500, 67877-501, 67877-502, 67877-499-30, 67877-499-90, 67877-500-30, 67877-500-90 +4 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 8, 2026
Reported by FDA DRUG
July 29, 2026
RecallRadar source check
August 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Ascend Laboratories, LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500-30. Generic: AMLODIPINE AND OLMESARTAN MEDOXOMIL; Brand: AMLODIPINE AND OLMESARTAN MEDOXOMIL. Reason: Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications. Classification: Class II. Quantity: 6,192 bottles. Distribution: Nationwide in the USA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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