Paxil
FDA Recall NDC 60505-3668
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 3 recorded enforcement report(s) associated with Paxil (NDC 60505-3668). A significant event, classified as Class II, was initiated on Aug 13, 2026 by Apotex Corp. The reported reason for this action was: "Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2026 Class II Recall: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Recall Number
Class II Ongoing
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Aug 13, 2026
Sep 02, 2026
6,972 bottles
Recall Profile & Regulatory Data
Event ID
99673
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Apotex Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Product Description
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Batch or Lot Expiration Information
Lot# TY9494, Exp Date: 05/31/2027.
Affected Packages Involved in this Recall
60505-4377-3Product
60505-4378-3Product
60505-4379-3Product
60505-3668-3Product
60505-3669-3Product
60505-3670-3Product
Class II Terminated
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Mar 24, 2014
Sep 10, 2014
N/A
Recall Profile & Regulatory Data
Event ID
68967
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 23, 2014
Product Description
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3670-3
Batch or Lot Expiration Information
Lot# 2E001; Exp. 05/15
Affected Packages Involved in this Recall
60505-4377-3Product
60505-4378-3Product
60505-4379-3Product
60505-3668-3Product
60505-3669-3Product
60505-3670-3Product
Class II Terminated
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Mar 24, 2014
Sep 10, 2014
N/A
Recall Profile & Regulatory Data
Event ID
68967
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Apotex Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Sep 23, 2014
Product Description
PAXIL CR (Paroxetine HCL) Controlled-Release Tablets 25 mg, 30-count bottle, Rx only, Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328, NDC 60505-3669-3
Batch or Lot Expiration Information
Lot# 2F004, Exp. 06/15
Affected Packages Involved in this Recall
60505-4377-3Product
60505-4378-3Product
60505-4379-3Product
60505-3668-3Product
60505-3669-3Product
60505-3670-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
