Apotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
Apotex Corp. is recalling Paroxetine Hydrochloride Extended-Release Tablets, 37.5mg, because they failed dissolution specifications.
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 or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Apotex Corp. is recalling Paroxetine Hydrochloride Extended-Release Tablets, 37.5mg, 30-count bottles. The recall was initiated because the product failed dissolution specifications.
The affected product is identified by NDC 60505-1318-3, Lot# TY9495, and an expiration date of 05/2027. The tablets were manufactured by Apotex Inc. in Toronto, Ontario, Canada, and distributed nationwide in the United States.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE HYDROCHLORIDE
- Manufacturer
- Apotex Corp.
- Category
- Drug — Prescription Medication
- Hazard
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# TY9495
- Exp Date: 05/2027.
UPCs (3)
- 0360505367436
- 0360505367535
- 0360505367337
Distribution
Distributed nationwide across the United States.
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