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.
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 2/5 (Moderate).
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.
- 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
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