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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Medichem S.A.: Chlorhexidine Gluconate Recalled for Bacterial Contamination

Agency Publication Date: September 9, 2020
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Summary

Approximately 117,800 kilograms of Chlorhexidine Gluconate (an active pharmaceutical ingredient) are being recalled because the bacteria Serratia marcescens was detected in certain batches. This product is a prescription drug component used for manufacturing, processing, or repacking medicinal products. Consumers and healthcare providers should be aware that the presence of this bacteria in non-sterile products can lead to serious infections, especially in vulnerable populations. This recall involves multiple batches distributed nationwide with expiration dates ranging from September 2021 to March 2022.

Risk

The product is contaminated with Serratia marcescens, a gram-negative bacillus that can cause healthcare-associated infections, including urinary tract infections, wound infections, and pneumonia. If used in the preparation of medical products, this contamination poses a significant risk of illness or infection to patients.

What You Should Do

  1. Identify if you have the affected Chlorhexidine Gluconate by checking the label for NDC 53296-0012-0 and the manufacturer Medichem S.A.
  2. Check your stock for the following specific batch numbers and expiration dates: A-190571 (Exp 11/29/21), A-190418 (Exp 09/04/21), A-190503 (Exp 10/25/21), A-190576 (Exp 12/02/21), A-190537 (Exp 11/15/21), A-200082 (Exp 02/24/22), A-200085 (Exp 02/25/22), A-200097 (Exp 03/05/22), A-200116 (Exp 03/13/22), A-200127 (Exp 03/19/22), and A-200131 (Exp 03/20/22).
  3. Immediately stop using the affected batches for any manufacturing, processing, or repacking activities.
  4. Contact your healthcare provider or pharmacist for guidance regarding any finished products that may have been created using these contaminated batches.
  5. Return any unused raw material to the place of purchase for a refund and contact Medichem S.A. for further instructions regarding disposal or return logistics.
  6. For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug product refund and consultation

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

Affected Products

Product: Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only (117,800 kg)
Model:
NDC 53296-0012-0
Recall #: D-1534-2020
Lot Numbers:
A-190571 (exp. 11/29/21)
A-190418 (exp. 09/04/21)
A-190503 (exp. 10/25/21)
A-190576 (exp. 12/02/21)
A-190537 (exp. 11/15/21)
A-200082 (exp. 02/24/22)
A-200085 (exp. 02/25/22)
A-200097 (exp. 03/05/22)
A-200116 (exp. 03/13/22)
A-200127 (exp. 03/19/22)
A-200131 (exp. 03/20/22)
Date Ranges: 09/04/21 - 03/20/22

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85869
Status: Resolved
Manufacturer: Medichem S.A.
Sold By: Pharmaceutical manufacturers; Repackers
Manufactured In: Spain
Units Affected: 117,800 kg
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.

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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.