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Drug Class II · moderate Ongoing

Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

Failed dissolution specifications.

Recalling firmApotex Corp.
ReasonFailed dissolution specifications.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateOct 7, 2026
InitiatedSep 23, 2026
RegionFL, United States
DistributionUS Nationwide.
Code/LotLot# TY9495, Exp Date: 05/2027.
TypeVoluntary: Firm initiated
Recall numberD-0877-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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