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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

Boehringer Ingelheim Pharmaceuticals, Inc.: Synjardy Tablets Recalled for Potential Cross-Contamination

Agency Publication Date: September 26, 2018
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Summary

Boehringer Ingelheim Pharmaceuticals, Inc. has recalled 998 bottles of Synjardy (empagliflozin and metformin hydrochloride) 5 mg/1000 mg tablets. This prescription medication, used to treat type 2 diabetes, is being recalled due to the potential for cross-contamination with other products during the manufacturing process. Consumers should immediately check their prescription bottles to see if they have the affected lot and contact their healthcare provider to discuss alternative treatment while the product is returned.

Risk

The tablets may have been contaminated with other medicinal products during manufacturing. This poses a risk of unintended exposure to secondary medications, which could cause adverse drug reactions or interfere with the effectiveness of the diabetes treatment.

What You Should Do

  1. Check your Synjardy (5 mg/1000 mg) 180-count prescription bottle for Lot # 603968 with an expiration date of 4/2019.
  2. Verify if the National Drug Code (NDC) on your bottle is 0597-0175-18.
  3. If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to report the issue.
  4. Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
  5. Contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 for further instructions regarding this recall.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy return

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

Affected Products

Product: Synjardy (empagliflozin and metformin hydrochloride) Tablets, 5 mg/1000 mg (180-count bottle)
Model:
NDC 0597-0175-18
Lot Numbers:
603968 (EXP 4/2019)
Date Ranges: Expiration date 4/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80961
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: Germany, United States
Units Affected: 998 180-count bottles
Distributed To: Nationwide
Agency Last Updated: September 27, 2018

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 · 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.