Apotex Recalls PAXIL Tablets Due to Chemical Contamination
Apotex Inc. is recalling PAXIL CR tablets because they were manufactured with active pharmaceutical ingredients contaminated with residual materials and solvents.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves chemical contamination with residual materials and solvents, which aligns with the rubric criterion for Severe (FDA Class II with significant risk).
Plain-English summary
Apotex Inc. is recalling PAXIL CR (Paroxetine HCL) Controlled-Release Tablets, 37.5 mg, 30-count bottles. The specific lot affected is Lot # 2E001 with an expiration date of 05/15. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because the product was manufactured with active pharmaceutical ingredient (API) batches that were contaminated with residual materials and solvents. This chemical contamination represents a potential risk to patients using the medication.
Consumers who have this specific lot of PAXIL CR should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- PAXIL (PAROXETINE HYDROCHLORIDE)
- Brand
- PAXIL
- Manufacturer
- Apotex Inc.
- Category
- Drug — Prescription Medication
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 (2)
- Lot # 2E001
- Exp. 05/15
UPCs (3)
- 0360505366835
- 0360505437733
- 0360505366934
Distribution
Part of a larger recall action
This product is one of 9 recalled by Apotex 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 9 products in this recall →Related recalls
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