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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.: SPIRIVA HandiHaler Inhalation Powder Recalled for Failed Stability

Agency Publication Date: January 26, 2018
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Summary

Boehringer Ingelheim Pharmaceuticals, Inc. is recalling 45,008 units of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule due to the product failing stability specifications. This medication, used for respiratory conditions, was distributed nationwide in boxes containing 90 capsules (unit dose blisters). Consumers should be aware that the medication may not perform as intended through its listed expiration date. You should contact your doctor or pharmacist to discuss continuing your treatment and obtaining a replacement if your medication is affected.

Risk

The product failed stability testing, which means the medication may lose its effectiveness or change in chemical composition before its expiration date, potentially leading to poorly controlled respiratory symptoms. No specific injuries have been reported at the time of this recall.

What You Should Do

  1. Check your SPIRIVA HandiHaler packaging for Lot # 606478 with an expiration date of 03/18 (March 2018).
  2. Verify the National Drug Code (NDC) on the box is 0597-0075-47 to confirm if your product is part of this recall.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you need a new prescription or replacement medication.
  4. Return any unused capsules from the affected lot to your pharmacy for a refund.
  5. Contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 for further instructions regarding this recall.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules)
Model:
NDC 0597-0075-47
Recall #: D-0242-2018
Lot Numbers:
606478 (Exp. 03/18)
Date Ranges: Expiration date: 03/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78775
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: Germany, United States
Units Affected: 45,008 units/90 capsules each unit
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 · 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.