The Recall Desk
HighFDA (Drugs)·D-0121-2024·Announced 2023-12-06

Paroxetine Hydrochloride 30 mg Tablets Recalled for Impurity Specification Failure

Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.

What this means for you

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: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The out-of-specification impurities represent a potential risk of harm where injury has not yet been reported, consistent with Score 3 per the severity rubric.

Plain-English summary

Apotex Corp. is recalling Paroxetine Hydrochloride Tablets USP 30 mg nationwide. The recall was initiated because testing identified out-of-specification impurities—specifically an Amadori Glucose adduct—in the drug substance, meaning the product failed to meet required purity standards.

The affected products include 30-count bottles (NDC 60505-0084-1, lot RV2254), 100-count bottles (NDC 60505-0084-2, lot RV8686), and 1000-count bottles (NDC 60505-0084-4, lot RX0119). All affected units have an expiration date of 08/2024. Approximately 25,776 units were distributed nationwide.

Patients currently taking this medication should consult their healthcare provider or pharmacist for guidance before making any changes to their treatment. Healthcare providers and pharmacists should stop dispensing the affected lots and contact patients who may have received this product.

The recalled product

Product
PAROXETINE (PAROXETINE HYDROCHLORIDE)
Brand
PAROXETINE
Manufacturer
Apotex Corp.
Category
Drug — Antidepressant / SSRI
Hazard
Affected units
25,776

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 (4)

  • Lot numbers: a)100 count bottle: RV8686
  • b) 1000 count bottle: RX0119
  • c) 30 count bottle: RV2254
  • 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 →

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