Reported Apr 21, 2021 · Terminated

Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc.,…

Macleods Pharma USA Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009

Is this the product you have?

  • Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only
  • Manufactured forMacleods Pharma USA, Inc., Plainsboro, NJ 08536
  • Manufactured byMacleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10
Lot codes and dates
    • Lots # : ECD5908C
    • Exp 7/2021
    • ECD5909A
    • ECD5910A
    • ECD5911A
    • ECD5912A
    • Exp. 09/2021
Amount recalled
8015 packs

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Macleods Pharma USA Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 13, 2022 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.