Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II recall for an out-of-specification impurity in a prescription medication. No illnesses or injuries have been reported, placing this within the High severity tier for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Apotex Corp. is recalling Paroxetine Hydrochloride Tablets USP, 40 mg in 1,000-count bottles due to failed quality control specifications. The recall involves 4,074 units distributed nationwide. The affected lot numbers are RV0131, RV2387, RV2389, RW3296, and RV2388, with expiration date 08/2024.
The recall was initiated due to out-of-specification results for the excipient Amadori Glucose adduct of Paroxetine. This indicates the product failed to meet FDA manufacturing quality standards.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this medication. Patients with affected lot numbers should contact their healthcare provider for guidance.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Apotex Corp.
- Category
- Drug
- Hazard
- Affected units
- 4,074
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 (6)
- Lot numbers: RV0131
- RV2387
- RV2389
- RW3296
- RV2388
- Exp. 08/2024
UPCs (4)
- 0360505010110
- 0360505008414
- 0360505009718
- 0360505008315
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · PAROXETINE
- HighParoxetine Tablets Recalled Due to Out-of-Specification Impurity Levels
FDA (Drugs) · 2023-12-06
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- ModerateParoxetine Tablets Recalled Due to Manufacturing Specification Failure
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Similar recalls
- HighParoxetine Tablets Recalled Due to Out-of-Specification Impurity Levels
FDA (Drugs) · 2023-12-06
- ModerateParoxetine 40 mg tablets recalled for out-of-specification impurities
FDA (Drugs) · 2023-12-06
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- SevereApotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination
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