FDA recall, , Moderate risk
Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets
Proin ER tablets failed dissolution specifications, which can affect drug release.
Summary by Recall Canary from the FDA notice
What happened
Pegasus Laboratories, Inc. recalled Proin ER, phenylpropanolamine hydrochloride extended-release tablets, 145mg Tablets, Net Contents 30 Tablets, for use in dogs, because the product failed dissolution specifications. The recall began July 20, 2026, and affected 7,248 bottles distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for recalled products:
- Check the brand, package size and codes such as expiration dates against the notice.
- Return it to the store where you bought it, or dispose of it properly.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Proin ER, phenylpropanolamine hydrochloride extended-release tablets
- NDC
- 49427-347-57
- 49427-347-44
- Lot code
- 25108A1
Recall details
- Company began the recall
- Sold in
- Nationwide
- Company
- Pegasus Laboratories, Inc.
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
It may cause short-term health problems in animals it is used on, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99455
- Recall number
- V-0183-2026
- Quantity recalled
- 7,248 bottles
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
