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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.: Mirapex (pramipexole dihydrochloride) Tablets Recalled for Low Tablet Weight

Agency Publication Date: March 11, 2019
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Summary

Boehringer Ingelheim Pharmaceuticals, Inc. has voluntarily recalled 112 folding cartons of Mirapex (pramipexole dihydrochloride) 1 mg tablets because routine testing identified tablets that weighed less than required specifications. These 100-count unit-dose cartons were distributed nationwide across the United States. Consumers who have this medication should check their packaging for the specific lot number and expiration date to see if their medicine is affected. If you have used this product, you should contact your healthcare provider or pharmacist for further guidance.

Risk

Low weight tablets may not contain the full amount of active medication required for treatment, which could result in a patient receiving a lower dose than prescribed. This could potentially lead to a reduction in the drug's effectiveness for managing symptoms.

What You Should Do

  1. Check your Mirapex (pramipexole dihydrochloride) 1 mg tablet packaging for NDC 0597-0190-61 and a quantity of 100 tablets per folding carton.
  2. Verify if your product matches Lot # AA3280A with an expiration date of September 2019 (Exp SEP 2019).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from the affected lot.
  4. Return any unused tablets from Lot # AA3280A to the pharmacy where they were purchased for a refund.
  5. Contact Boehringer Ingelheim Pharmaceuticals, Inc. directly for further instructions regarding this recall.
  6. For additional questions or to report a concern, call 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

Healthcare provider consultation and pharmacy return

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

Affected Products

Product: Mirapex (pramipexole dihydrochloride) Tablets, 1 mg (100-count unit-dose)
Model:
0597-0190-61
Lot Numbers:
AA3280A (Exp SEP 2019)
Date Ranges: September 2019 (Expiration Date)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82310
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: Germany
Units Affected: 112 folding cartons
Distributed To: Nationwide

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.