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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

Boehringer Ingelheim Pharmaceuticals, Inc.: Mobic (meloxicam) Tablets Recalled for Incorrect Package Insert

Agency Publication Date: October 6, 2017
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Summary

Boehringer Ingelheim Pharmaceuticals is recalling 128 bottles of Mobic (meloxicam) 15 mg tablets because they were packaged with the wrong information insert. Mobic is a prescription medication used to treat pain and inflammation from arthritis. Because the package insert contains critical safety information, usage instructions, and warning details for patients and healthcare providers, having the incorrect insert could lead to a misunderstanding of how to use the medication safely or a failure to recognize important side effects. This recall affects 100-count bottles from one specific lot distributed in Colorado and Ohio.

Risk

The incorrect package insert may provide inaccurate dosage instructions or omit vital safety warnings, potentially leading to improper use of the medication or unrecognized adverse reactions.

What You Should Do

  1. Locate your Mobic (meloxicam) 15 mg 100-count bottle (NDC 0597-0030-01) and check the label for Lot 754037.
  2. If your bottle matches Lot 754037, verify the package insert included with the medication to see if it matches the prescribed drug.
  3. Contact your healthcare provider or pharmacist immediately to discuss the recall and ensure you have the correct prescribing information for your medication.
  4. Return any unused product from the affected lot to your pharmacy to receive a refund and a replacement with the correct labeling.
  5. Contact Boehringer Ingelheim Pharmaceuticals, Inc. at their Danbury, CT location for further instructions regarding this voluntary recall.
  6. For additional questions or to report a problem, 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

Patient and pharmacist guidance and product return.

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

Affected Products

Product: Mobic (meloxicam) tablets, 15 mg (100-count bottle)
Model:
NDC 0597-0030-01
Recall #: D-0007-2018
Lot Numbers:
754037

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78172
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: Italy, United States
Units Affected: 128 bottles
Distributed To: Colorado, Ohio

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.