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.
What this means for you
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 (PAROXETINE HYDROCHLORIDE)
- Brand
- PAXIL
- 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.
UPCs (3)
- 0360505366835
- 0360505437733
- 0360505366934
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2014-09-10
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