The Recall Desk
ModerateFDA (Drugs)·D-0130-2024·Announced 2023-12-06

Paroxetine 40 mg tablets recalled for out-of-specification impurities

Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets due to failed impurity specifications. A total of 5,626 bottles were distributed nationwide.

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: This is an FDA Class II pharmaceutical recall based on quality-control testing rather than reported illnesses or injuries. The out-of-specification impurities represent a precautionary concern, warranting a Moderate-severity classification consistent with voluntary precautionary recalls.

Plain-English summary

Golden State Medical Supply Inc. is recalling Paroxetine 40 mg tablets, USP, due to failed impurity and degradation specifications. The tablets were manufactured by Apotex Inc. in Toronto, Ontario, Canada, and packaged by GSMS Inc. in Camarillo, California.

The recall affects three package sizes: 30-count bottles (NDC 60429-737-30), 90-count bottles (NDC 60429-737-90), and 1,000-count bottles (NDC 60429-737-10). Affected lot numbers include GS036488, GS037091, GS037701, GS037090, GS037702, GS036677, GS037117, and GS037699, all with an expiration date of August 31, 2024.

Out-of-specification results were detected for the excipient Amadori Glucose adduct of Paroxetine, indicating the presence of degradation products beyond acceptable limits. A total of 5,626 bottles were distributed nationwide throughout the United States.

The recalled product

Product
PAROXETINE (PAROXETINE HYDROCHLORIDE)
Brand
PAROXETINE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Psychiatric / SSRI
Hazard
Affected units
5,626

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 (9)

  • Lot # a) GS036488
  • GS037091
  • GS037701
  • Exp. 08/31/2024
  • b) GS037090
  • GS037702
  • c) GS036677
  • GS037117
  • GS037699

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Golden State Medical Supply Inc. 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 3 products in this recall →

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Same hazard · impurity

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