FDARecall 99673Medicines
What to do
The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.
Read the official notice on accessdata.fda.gov (opens in a new tab)
Hazard
Why it was recalled
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.
Is it yours? Products and codes
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
- Lot or code
- Lot # TY9494, Exp Date: 05/31/2027.
- FDA recall number
- D-0804-2026
- Quantity
- 6,972 bottles
Distribution (FDA): US Nationwide.
About this record
- Issued by
- U.S. Food and Drug Administration
- Firm
- Apotex Corp.
- Title
- Composed by Recalls Watch from fields of the record; FDA records have no title.