Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Amlodipine and Olmesartan Medoxomil Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: low dissolution results
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Affected NDC
67877-0501-30
Compare with the code on your package — it is the most precise check available.
Drug: Amlodipine Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Amlodipine and olmesartan Medoxomil NDC 67877-0501 |
AMLODIPINE BESYLATE 5 mg/1; OLMESARTAN MEDOXOMIL 40 mg/1 | Tablet Oral |
Ascend Laboratories, LLC | Rx |
- Recalling firm
- Ascend Laboratories, LLC
- NDC code
- 67877-501-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0576-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Amlodipine recalls
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Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk
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Amlodipine Besylate Tablets
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Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
cGMP deviations
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Class III · Low risk
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Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
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