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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Aurobindo Pharma USA Inc.: Amlodipine and Olmesartan Medoxomil Tablets Recalled for Color Discoloration

Agency Publication Date: December 6, 2018
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Summary

Aurobindo Pharma USA Inc. is recalling 4,464 bottles of Amlodipine and Olmesartan Medoxomil tablets (5 mg/40 mg), a prescription blood pressure medication. The recall was initiated after a pharmacist reported that the tablets in a specific lot were pink instead of the correct cream (peach) color. Using a medication that does not match its physical description can lead to confusion and incorrect dosing.

Risk

The tablets in the affected lot may be the wrong color, which indicates a potential manufacturing error or product mix-up. This poses a risk of medication error where a patient might take the wrong drug or dosage, potentially failing to control their blood pressure or experiencing unexpected side effects.

What You Should Do

  1. Check your prescription bottle for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, in 30-count bottles with NDC 65862-855-30.
  2. Locate the lot number and expiration date on the side of the bottle; this recall specifically affects Lot OWSA18002-A with an expiration date of July 2020 (7/2020).
  3. Inspect the tablets inside the bottle; if the tablets are pink instead of cream or peach colored, they are affected by this recall.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking your medication.
  5. Return any unused product from the affected lot to your pharmacy for a refund and further instructions.
  6. Contact Aurobindo Pharma USA Inc. at 1-866-850-2876 for more information regarding this recall.
  7. 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

๐Ÿ’ฐFull 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 and Olmesartan Medoxomil Tablets, 5 mg/40 mg (30-count bottle)
Model:
NDC 65862-855-30
Lot Numbers:
OWSA18002-A (Exp 7/2020)
Date Ranges: Expiration 7/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81703
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 4464 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 ยท 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.