Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels
Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.
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 for pharmaceutical impurity. The classification indicates potential risk of harm, but no illnesses or injuries have been reported, consistent with the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Paroxetine tablets, USP, 10 mg are being recalled due to failed quality control specifications. Manufactured by Apotex Inc. and packaged by GSMS Inc., certain lots contain out-of-specification levels of Amadori Glucose adduct of Paroxetine, a degradation impurity.
Approximately 1,941 bottles are affected, distributed nationwide in the United States. The recalled product is available in 30-count (NDC 60429-734-30), 90-count (NDC 60429-734-90), and 1,000-count (NDC 60429-734-10) bottles with expiration dates of August 31, 2024.
Consumers with affected medication should contact their pharmacy or healthcare provider for guidance. The recalling firm is Golden State Medical Supply Inc.
The recalled product
- Product
- PAROXETINE (PAROXETINE HYDROCHLORIDE)
- Brand
- PAROXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug
- Hazard
- Affected units
- 1,941
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) Lot GS041383
- GS042141
- Exp. 08/31/2024
- b) Lot GS040841
- Lot GS041384
- Lot GS042039
- c) Lot GS040910
- Lot GS041621
- Lot GS042237
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
- ModerateParoxetine 20 mg Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06
- HighParoxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06
- ModerateParoxetine 40 mg tablets recalled for out-of-specification impurities
FDA (Drugs) · 2023-12-06
- HighParoxetine Hydrochloride 30 mg Tablets Recalled for Impurity Specification Failure
FDA (Drugs) · 2023-12-06
- HighParoxetine 10 mg tablets recalled nationwide for out-of-specification impurities
FDA (Drugs) · 2023-12-06
Same manufacturer · Golden State Medical Supply Inc.
See all →- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighBaclofen tablet bottles recalled over the presence of foreign tablets
FDA (Drugs) · 2025-12-24
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17