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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Caduet Tablets Recalled for Defective Sealing and Moisture Risk

Agency Publication Date: February 13, 2020
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Summary

Pfizer Inc. is recalling approximately 269 bottles of Caduet (amlodipine besylate/atorvastatin calcium) tablets because they may have been packaged in defective bottles with notched rims. This physical defect can prevent the foil seal from closing properly, potentially exposing the medication to moisture and compromising its effectiveness or stability. The recall affects 30-count bottles of two different dosage strengths distributed nationwide. If you have this medication, you should contact your doctor or pharmacist to discuss your treatment and return the affected product to the pharmacy for a refund.

Risk

A notched rim on the medication bottle can cause an inadequate foil seal, allowing moisture to enter the container. This moisture can degrade the active ingredients in the medication, potentially making it less effective at treating high blood pressure and high cholesterol.

What You Should Do

  1. Check your prescription bottle of Caduet (amlodipine besylate/atorvastatin calcium) to see if it matches the affected NDC and lot numbers.
  2. Identify if you have Caduet 10 mg/20 mg tablets in 30-count bottles with NDC 0069-2180-30, lot number CY0937, and an expiration date of 12/2021.
  3. Identify if you have Caduet 10 mg/10 mg tablets in 30-count bottles with NDC 0069-2160-30, lot number CY0963, and an expiration date of 07/2022.
  4. Contact your healthcare provider or pharmacist immediately for guidance on whether you should continue taking the medication or receive a replacement.
  5. Return any unused, affected product to the pharmacy or place of purchase for a refund and contact Pfizer Inc. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg (30-count bottle)
Model:
NDC 0069-2180-30
D-0841-2020
Lot Numbers:
CY0937 (Exp 12/2021)
Product: Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg (30-count bottle)
Model:
NDC 0069-2160-30
D-0842-2020
Lot Numbers:
CY0963 (Exp 07/2022)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84860
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Pharmacies
Manufactured In: Germany, United States
Units Affected: 2 products (141 bottles; 128 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.