PlainRecordsProin ER…
- Reason
- Failed dissolution specifications
- Status
- Ongoing
- Distribution
- Nationwide
- Enforcement report date
- Aug. 5, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in FDA's Enforcement Report data of the last download)
- Filed by
- Pegasus Laboratories, Inc.
- Product
- Proin ER, phenylpropanolamine hydrochloride extended-release tablets, 145mg Tablets, Net Contents 30 Tablets, Manufactured by: Pegasus Laboratories, Inc., Employee-owned Pensacola, FL 32514, USA, NDC 49427-347-57, for use in dogs
- Reason
- Failed dissolution specifications
- Distribution pattern
- Nationwide
- Quantity
- 7,248 bottles
- Codes and lots
- Lot# 25108A1
- Recall started
- July 20, 2026
- Voluntary or mandated
- Voluntary: Firm Initiated
- Recall number
- V-0183-2026
What the record says about this drug
A simplified drawing of a vial, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Failed dissolution specifications”Proin ER, phenylpropanolamine hydrochloride extended-release tablets, 145mg Tablets, Net Contents 30 Tablets, Manufactured by: Pegasus Laboratories, Inc., Employee-owned Pensacola, FL 32514, USA, NDC 49427-347-57, for use in dogs, FDA veterinary enforcement report, 2026-08-05. The caption is the record's own words.
A generic vial, not the product. The mark follows the record's own words (a question mark, where used, stands for a lack of assurance the record names, not for anything found).
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This recall among the others
- FDA's enforcement report came 16 days after the firm started the recall. For half of the 60 FDA veterinary recall events reported in 2026 so far with a start date, it took 21 days or fewer (by year).
- Pegasus Laboratories: 4 other recalls or notices on this site in the three years before this one (from Aug. 6, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? Pet food recall: what to do · How to read this record
Source: FDA · Animal and veterinary enforcement report, recall number V-0183-2026. See this record in FDA's Enforcement Report. The agency record governs; check it and the company before acting.
Cite this record
FDA recall record V-0183-2026, Aug. 5, 2026. "Proin ER." PlainRecords, https://plainrecords.com/recall/vet/v-0183-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections