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Unrated Drug recall · FDA · Published November 30, 2018

Aurobindo Pharma recalls pink Amlodipine/Olmesartan tablets due to discoloration

Aurobindo Pharma recalls 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets that were pink instead of cream. This is a pharmacist-reported discoloration issue for prescription use.

🇺🇸 FDA recall #D-0289-2019DrugAurobindo Pharma ›
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Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aurobindo Pharma is recalling prescription 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets that were reported to be pink instead of cream. This discoloration could indicate a manufacturing issue that might affect the medication's safety or effectiveness. Read more at govinfonow.com/recall/39399-aurobindo-pharma-recalls-pink-amlodipine-olmesartan-tablets-due-to-discoloration.

Source Summary by GovInfoNow · govinfonow.com/recall/39399-aurobindo-pharma-recalls-pink-amlodipine-olmesartan-tablets-due-to-discoloration · Updated October 5, 2026 · FDA enforcement record: FDA #D-0289-2019

Cite this page

“Aurobindo Pharma recalls pink Amlodipine/Olmesartan tablets due to discoloration.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39399-aurobindo-pharma-recalls-pink-amlodipine-olmesartan-tablets-due-to-discoloration. Based on FDA recall #D-0289-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0289-2019%22&limit=1).

Why it’s dangerous

The tablets were reported to be pink instead of the expected cream (peach) color by pharmacists. This discoloration could indicate a manufacturing issue that might affect the medication's safety or effectiveness, though the exact risk is not specified in the recall.

Who’s affected

Prescription patients who have the 30-count bottle of Amlodipine and Olmesartan Medoxomil tablets (5 mg/40 mg) with the lot number OWSA18002-A. Those who have the tablets and are taking them as prescribed are most at risk.

How to tell if you have this one

Check for the 30-count bottle labeled 'Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg' with lot number OWSA18002-A. The tablets should be cream (peach) color, not pink.

  • Brand
    Aurobindo Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Tablet Color

    Look for pink tablets instead of the expected cream (peach) color.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Nov 30, 201812. FDA classified it Class III: Dec 6, 201823. Published in FDA’s Enforcement Report: Dec 12, 201834. FDA terminated the recall: Feb 1, 2022420182022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0289-2019 (November 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0289-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA