Apotex recall: Paroxetine Extended-Release Tablets
Apotex Corp. is recalling Paroxetine Extended-Release Tablets. The U.S. Food and Drug Administration published the recall on October 7, 2026; it began on September 23, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Paroxetine Extended-Release Tablets |
| Brand | Apotex |
| Company | Apotex Corp. |
| Type | Drugs |
| Classification | Class II |
| Recall date | September 23, 2026 |
| Published by FDA | October 7, 2026 |
| Recall ID | 99978 |
Recalled products
- 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
- FDA recall number
- D-0877-2026
- Codes, lots and dates
- Lot# TY9495, Exp Date: 05/2027.
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99978
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Weston, FL, United States
Why it was recalled
The reason the FDA lists: “Failed dissolution specifications.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99978, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Apotex recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 2, 2026 |  Apotex recall: Paxil CRDrugs · 6,972 bottles | Failed Dissolution Specifications; product failed to meet 24-month stability testing accep… Serious | FDA Class II |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
| Oct 7, 2026 | SV Labs Toronto recall: Benzoyl Peroxide WashDrugs | microbial contamination Serious | FDA Class II |
About this recall
Is Apotex Paroxetine Extended-Release Tablets recalled?
Yes. Apotex Corp. recalled it on September 23, 2026; FDA published it October 7, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Failed dissolution specifications.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.