Ascend amlodipine and olmesartan tablets failed dissolution specifications
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, are being recalled after failing dissolution specifications, with olmesartan medoxomil content below specification.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a failed dissolution specification with active ingredient below specification, a risk of harm with no injuries reported.
Plain-English summary
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, in 30-count bottles, manufactured by Alkem Laboratories Ltd. in India and distributed by Ascend Laboratories, LLC of Parsippany, New Jersey, NDC 67877-501-30, are being recalled. The action covers 15,696 bottles of 30.
The stated reason is failed dissolution specifications, with olmesartan medoxomil content below specifications. Dissolution testing measures how a tablet releases its active ingredient. The FDA classified the action as Class II.
The affected lot is 24123460, expiring 31 October 2027. Distribution was USA nationwide.
This is a prescription blood pressure medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Antihypertensive tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot: 24123460
- Expires: October 31
- 2027.
Distribution
Distributed nationwide across the United States.
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