RecallReported September 2, 2026
Class II recall by Apotex Corp.
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L…
FDA's enforcement report of September 2, 2026 lists a Class II recall by Apotex Corp. of Weston, FL. Product: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L…. Status: Ongoing.
On the record
- Recalling firm
- Apotex Corp.
- Location
- Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0804-2026
- Product type
- Drugs
- Brand names
- PAXIL
- Generic names
- PAROXETINE HYDROCHLORIDE
- Recall initiated
- 2026-08-13
- Reported by FDA
- 2026-09-02
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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