Apotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
Apotex Corp. is recalling 6,972 bottles of Paxil CR 37.5mg tablets because the product failed dissolution specifications and 24-month stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving quality control failures without reported harm.
Plain-English summary
Apotex Corp. is recalling 6,972 bottles of Paxil CR (paroxetine hydrochloride) extended-release tablets, 37.5mg, 30 count. The affected product is identified by Lot # TY9494 with an expiration date of 05/31/2027. The recall was initiated because the product failed to meet dissolution specifications and did not meet 24-month stability testing acceptance criteria.
The affected medication was distributed nationwide in the United States. Paxil is a prescription-only medication manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida.
Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- 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
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 6,972
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # TY9494
- Exp Date: 05/31/2027.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Apotex Corp.
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateApotek desmopressin nasal spray recalled over dislodged or missing cap liners
FDA (Drugs) · 2026-04-22
- HighBrimonidine and timolol eye drops recalled over sterility assurance failure
FDA (Drugs) · 2026-03-25
- HighKetorolac ophthalmic solution recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
- HighGlaucoma eye drops recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
Same hazard · quality control
See all →- HighBaxter Recalls CARDENE IV Nicardipine Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls MYXREDLIN Insulin Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateApotex Recalls Duloxetine Capsules Due to Dissolution Failure
FDA (Drugs) · 2016-07-20
- LowApotex Recalls Duloxetine Capsules Due to Failed Dissolution Testing
FDA (Drugs) · 2016-07-20
- SevereApotex Recalls PAXIL CR Tablets Due to Chemical Contamination
FDA (Drugs) · 2014-09-10
- SevereApotex Recalls PAXIL Tablets Due to Chemical Contamination
FDA (Drugs) · 2014-09-10
- LowApotex Recalls Verapamil Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2015-10-07