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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Amlodipine Besylate Tablets Recalled Due to Mislabeling and Incorrect Dosage

Agency Publication Date: September 11, 2017
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Summary

Ascend Laboratories LLC is recalling 1,212 bottles of Amlodipine Besylate 10 mg tablets because a lower dose 2.5 mg tablet was found mixed inside a bottle labeled as 10 mg. This recall affects 1000-count prescription bottles of Amlodipine Besylate, a medication used to treat high blood pressure. Consumers who inadvertently take the 2.5 mg tablet instead of their prescribed 10 mg dose may not receive the intended therapeutic effect. If you have this medication, you should consult your healthcare provider or pharmacist immediately to ensure your tablets are correct.

Risk

Taking a 2.5 mg tablet when a 10 mg dose is prescribed results in receiving only one-quarter of the intended medication, which may lead to poorly controlled blood pressure or other cardiovascular complications.

What You Should Do

  1. Check your prescription bottle of Amlodipine Besylate 10 mg (1000-count) for Lot #: 6142626 with an expiration date of 09/19.
  2. Verify the tablets inside the bottle; this recall was initiated because a single 2.5 mg tablet was found co-mingled with the 10 mg tablets.
  3. If you identify an incorrect tablet size or have the affected lot number, contact your healthcare provider or pharmacist immediately for guidance and to obtain a correct supply.
  4. Return any unused product from the affected lot to your pharmacy for a refund.
  5. Contact Ascend Laboratories LLC or the manufacturer, Alkem Laboratories Ltd., for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: AMLODIPINE BESYLATE TABLET, USP, 10 mg (1000 count bottle)
Model:
NDC 67877-199-10
Recall #: D-1134-2017
Lot Numbers:
6142626 (Exp 09/19)
Date Ranges: Expiration 09/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 77948
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 1212 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.