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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

Proin ER (phenylpropanolamine) Tablets Recalled for Dissolution Test Failure

Agency Publication Date: September 15, 2025
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Summary

Pegasus Laboratories, Inc. is voluntarily recalling 2,376 bottles of Proin ER (phenylpropanolamine hydrochloride extended-release tablets), 145 mg, used for urinary incontinence in dogs. The recall was initiated because the product failed a long-term stability dissolution test at the 16-hour mark, meaning the medication may not release properly over time. This issue affects one specific lot, 25079A1, which contains 90-count bottles distributed nationwide.

Risk

If the medication does not dissolve and release according to specifications, the dog may not receive the intended dose at the correct time, potentially reducing the effectiveness of the treatment for urinary incontinence.

What You Should Do

  1. Check your Proin ER 145 mg (90-count) bottle for lot number 25079A1 with an expiration date of 02/27.
  2. If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer or supplier for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: If you have animal health concerns, contact your veterinarian. Return any unused product to the place of purchase for a refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: PROIN ER (Phenylpropanolamine hydrochloride extended-release tablets), 145 mg (90 tablets)
Variants: 145 mg, Extended-release tablet
Lot Numbers:
25079A1 (Exp 02/27)

Recall #: V-0112-2025; Quantity: 2,376 bottles/198 cases

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97578
Status: Active
Manufacturer: Pegasus Laboratories, Inc.
Sold By: Veterinary clinics; Authorized distributors
Manufactured In: United States
Units Affected: 2,376 bottles/198 cases
Distributed To: Nationwide
Agency Last Updated: September 26, 2025

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 ยท Raw API Response