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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 Vet
Pets & Animals/Pet Medications

Pegasus Laboratories, Inc.: Proin 75 mg Chewable Tablets Recalled for Mislabeling and Incorrect Dosage Info

Agency Publication Date: July 17, 2012
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Summary

Pegasus Laboratories, Inc. is recalling approximately 34,685 bottles of Proin 75 mg (phenylpropanolamine hydrochloride) chewable tablets for dogs. The recall was issued because certain 60-count bottles may have an incorrect 25 mg instruction booklet attached to a 75 mg base label, which could lead to incorrect dosing of the medication. This veterinary drug is used to control urinary incontinence in dogs. Affected products were distributed to veterinary clinics and distributors in multiple states including California, Florida, New York, and Texas.

Risk

The mismatch between the 75 mg bottle strength and the 25 mg dosing instructions poses a risk of medication errors. If a pet owner follows the incorrect instructions in the booklet, the dog may receive a dose that is significantly higher or lower than intended by the veterinarian, potentially leading to ineffective treatment or adverse health effects.

What You Should Do

  1. Check your Proin 75 mg 60-count bottle for Lot Numbers 120213 or 120416, which are the only lots affected by this recall.
  2. Inspect the label carefully: look for bottles that have a 'Proin 75 mg' base label but contain an attached booklet or insert that incorrectly identifies the product as 'Proin 25 mg'.
  3. If you have an affected bottle, do not administer the medication based on the instructions found in the 25 mg booklet.
  4. Contact your veterinarian or the pharmacy where you purchased the medication to report the issue and receive guidance on proper dosing or product replacement.
  5. Return any unused product from the affected lots to your veterinarian or the place of purchase for a full refund.
  6. Contact Pegasus Laboratories, Inc. at their Pensacola, Florida facility for further instructions regarding this recall.
  7. For additional questions, contact the FDA Center for Veterinary Medicine at 1-240-276-9300.

Your Remedy Options

💰Full Refund

Refund and veterinary consultation

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

Affected Products

Product: PROIN 75 mg Chewable Tablets (60-count bottle)
Model:
NADA #141-324
Lot Numbers:
120213
120416

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 61940
Status: Resolved
Manufacturer: Pegasus Laboratories, Inc.
Sold By: Veterinary clinics; Veterinary distributors
Manufactured In: United States
Units Affected: 34,685
Distributed To: Florida, Oregon, Ohio, Pennsylvania, California, Texas, Missouri, New York, Minnesota, Iowa, Nebraska, New Jersey

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