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
- impurity
- degradation-product
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.
Related recalls
Same brand · PAROXETINE
- HighParoxetine 10 mg tablets recalled nationwide for out-of-specification impurities
FDA (Drugs) · 2023-12-06
- HighParoxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2023-12-06
- ModerateParoxetine Tablets Recalled Due to Manufacturing Specification Failure
FDA (Drugs) · 2023-12-06
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27