Life sciences · Safety recall

Class II recall: Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured f

U.S. Food and Drug Administration · September 2, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA issued a Class II voluntary recall of Paxil CR 37.5 mg tablets manufactured by Apotex Inc. due to failure to meet dissolution specifications and 24-month stability testing criteria. This is a product quality and manufacturing defect affecting potential bioavailability; no clinical trial data or adverse event outcomes are reported in this regulatory notice.

What was studied

Safety recall. Patients prescribed Paxil CR 37.5 mg nationwide in the United States; exact number of affected units or patients not stated.. Manufactured by Apotex Inc., Toronto, Ontario, Canada; distributed US Nationwide.

Key findings

Paxil CR 37.5 mg, 30 count bottles (NDC 60505-4379-3) failed dissolution specifications Product failed to meet 24-month stability testing acceptance criteria Recall classified as Class II and initiated voluntarily by Apotex Corp.

Safety

Recall notice does not report clinical adverse events, patient harm, or clinical efficacy data.

Who this may help

Clinicians and patients using this product should verify their supply against the recalled NDC and batch codes. The dissolution and stability defects may result in subtherapeutic drug exposure; prescribers should consider alternative sources or formulations pending resolution.

Plain-language summary

FDA Class II recall of Paxil CR 37.5 mg due to failed dissolution specifications and stability testing; affects product quality and bioavailability but does not report clinical outcomes.

Study design

As stated by the source record.

SettingManufactured by Apotex Inc., Toronto, Ontario, Canada; distributed US Nationwide

Reported figures

Quoted from the source exactly as published.

Dose and formulation37.5 mg extended-release tablets

NDC60505-4379-3

Package size30 count bottle

Recall classificationClass II

Stability testing duration24-month

Clinical bottom line

Caveats

Recall notice does not report clinical adverse events, patient harm, or clinical efficacy data.
Specific batch numbers, lot codes, and quantity of units recalled not provided.
Number of patients affected or clinical consequences of failed dissolution not quantified.
Recall status reported as 'Ongoing'; final disposition and completion not stated.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory enforcement action; no clinical study design applicable.

Directness

insufficient

Recall notice does not report clinical efficacy or safety data.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Manufacturing and stability testing data not detailed in recall notice.

Sample adequacy

insufficient

Recall applies to nationwide distribution; specific batch or affected patient numbers not stated.

Source abstract

FDA enforcement report D-0804-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: Apotex Corp.. Initiated as: Voluntary: Firm initiated. Product: Paxil CR, 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 60505-4379-3 Reason for recall: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Distribution: US Nationwide.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Apotex