The Recall Desk
ModerateFDA (Drugs)·D-0129-2024·Announced 2023-12-06

Paroxetine 20 mg Tablets Recalled for Out-of-Specification Impurity

Golden State Medical Supply is recalling certain lots of Paroxetine 20 mg tablets nationwide due to an out-of-specification chemical impurity in the product.

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 drug recall with no reported illnesses or injuries. The hazard is a chemical impurity (degradation product) that failed quality specifications, representing a theoretical rather than demonstrated safety risk. Per the rubric, recalls with no reported illnesses and theoretical hazards warrant a Moderate severity rating.

Plain-English summary

Golden State Medical Supply Inc. is recalling specific lots of Paroxetine 20 mg tablets packaged in 90-count and 1000-count bottles due to a manufacturing quality issue identified by the manufacturer, Apotex Inc.

The recall was initiated because the tablets contain an out-of-specification level of an impurity known as Amadori Glucose adduct of Paroxetine, which is a degradation product. This impurity resulted from a failure to meet the FDA's established chemical purity and degradation specifications for this medication.

The affected products were distributed nationwide in the USA. The recall involves 2502 bottles across two packaging sizes: NDC 60429-735-90 (90-count) and NDC 60429-735-10 (1000-count). Specific lot numbers affected are GS036696, GS037068, GS037934, GS038564, GS036381, GS036712, GS037116, GS037692, and GS038388, all with an expiration date of 08/31/2024.

The recalled product

Product
PAROXETINE (PAROXETINE HYDROCHLORIDE)
Brand
PAROXETINE
Manufacturer
Golden State Medical Supply Inc.
Category
Drug — Prescription Antidepressant
Hazard
Affected units
2,502

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 (10)

  • Lot # a) GS036696
  • GS037068
  • GS037934
  • GS038564
  • Exp. 08/31/2024 b) GS036381
  • GS036712
  • GS037116
  • GS037692
  • GS038388
  • Exp. 08/31/2024

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 →

Related recalls

Same brand · PAROXETINE

Same manufacturer · Golden State Medical Supply Inc.

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Same hazard · impurity

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