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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

Macleods Pharma Usa Inc: Candesartan Cilexetil Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: April 12, 2021
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Summary

Macleods Pharma USA, Inc. is voluntarily recalling approximately 8,015 packs of Candesartan Cilexetil (4 mg) prescription blood pressure tablets because the medication failed to meet laboratory specifications for impurities and degradation. These 30-count bottles were distributed nationwide in the United States and were manufactured by Macleods Pharmaceuticals Ltd. in India. Consumers who have these tablets should consult their doctor or pharmacist regarding their treatment and return the product to their pharmacy for a refund.

Risk

The tablets may contain impurities or degradation products that exceed safety limits. While this recall is considered low risk, consuming medication with failed impurity specifications means the drug's safety and effectiveness over time cannot be guaranteed.

What You Should Do

  1. Check your prescription bottle for Candesartan Cilexetil Tablets, USP, 4 mg, in 30-count bottles with NDC number 33342-114-10.
  2. Verify the lot and expiration information on the label: look for Lot ECD5908C (Exp 7/2021) or Lots ECD5909A, ECD5910A, ECD5911A, and ECD5912A (all with Exp 09/2021).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking the medication.
  4. Return any unused tablets from the affected lots to your pharmacy to receive a refund.
  5. Contact Macleods Pharma USA, Inc. at their Plainsboro, New Jersey office for further instructions regarding the return of the product.
  6. If you have questions for the FDA, you may 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

Return unused product 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: Candesartan Cilexetil Tablets, USP, 4 mg (30-count bottle)
Model:
NDC 33342-114-10
Recall #: D-0329-2021
Lot Numbers:
ECD5908C (Exp 7/2021)
ECD5909A (Exp. 09/2021)
ECD5910A (Exp. 09/2021)
ECD5911A (Exp. 09/2021)
ECD5912A (Exp. 09/2021)
Date Ranges: Expiration 7/2021, Expiration 09/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87607
Status: Resolved
Manufacturer: Macleods Pharma Usa Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 8015 packs
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.