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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 Vet
Pets & Animals/Pet Medications

Boehringer Ingelheim Animal Health USA Inc: Heartgard (ivermectin) Chewables Recalled for Impurity Specifications

Agency Publication Date: August 21, 2020
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Summary

Boehringer Ingelheim Animal Health USA Inc. has voluntarily recalled 14,830 cartons of Heartgard (ivermectin) chewables for dogs after testing revealed an impurity that was out of specification. This recall affects three specific product strengths: for dogs up to 25 lbs, 26-50 lbs, and 51-100 lbs. These products were distributed throughout the United States to veterinarians and retail channels. Consumers should check their pet's medication packaging for the specific batch numbers and expiration dates to determine if their product is affected.

Risk

The product contains an impurity level that does not meet approved quality standards, which could potentially impact the stability or efficacy of the heartworm preventative medication.

What You Should Do

  1. Check your Heartgard (ivermectin) packaging to see if your product matches one of the following batches: Batch B195313 (Dogs up to 25 lbs, UPC 3 50604 40231 2), Batch B195314 (Dogs 26-50 lbs, UPC 3 50604 40241 1), or Batch B195315 (Dogs 51-100 lbs, UPC 3 50604 40251 0).
  2. Verify if the expiration date on the package is listed as 11/21 (November 2021).
  3. If your product is part of this recall, contact your veterinarian or the pharmacist where you purchased the medication to discuss alternative treatment and instructions for the affected tablets.
  4. Return any unused tablets to the pharmacy or place of purchase for a refund.
  5. Contact Boehringer Ingelheim Animal Health USA Inc. at their Duluth, GA headquarters or through your veterinarian for further technical instructions.
  6. For additional questions or to report adverse events, contact the FDA Center for Veterinary Medicine (CVM) at 240-402-7002.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return unused product for a refund.

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

Affected Products

Product: Heartgard (ivermectin) For Dogs Up To 25 lbs (6 Tablets)
Model:
V-0468-2020
UPC Codes:
350604402312
Lot Numbers:
Batch Number: B195313
Date Ranges: Exp. 11/21
Product: Heartgard (ivermectin) For Dogs 26-50 lbs (6 Tablets)
Model:
V-0469-2020
UPC Codes:
350604402411
Lot Numbers:
Batch Number: B195314
Date Ranges: Exp. 11/21
Product: Heartgard (ivermectin) For Dogs 51-100 lbs (6 Tablets)
Model:
V-0470-2020
UPC Codes:
350604402510
Lot Numbers:
Batch Number: B195315
Date Ranges: Exp. 11/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86229
Status: Resolved
Manufacturer: Boehringer Ingelheim Animal Health USA Inc
Sold By: Veterinary clinics; Animal health retailers
Manufactured In: United States
Units Affected: 3 products (5400 cartons; 3480 cartons; 5950 cartons)
Distributed To: Nationwide
Agency Last Updated: August 27, 2020

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