FDA Drugs recall ·
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle… recall
- Recall number
- D-0804-2026
- Date
- (initiated August 13, 2026)
- Company / brand
- Apotex Corp.
2400 N Commerce Pkwy Ste 400, Weston, FL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,972 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # TY9494, Exp Date: 05/31/2027.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0804-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.