CLASS II Drug recall · Reported 10 Sep 2014 · FDA Enforcement Report

Paxil CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg recalled

Apotex is recalling Paxil CR (Paroxetine HCL) Controlled-Release Tablets 37.5 mg, distributed nationwide in the US. The recall was initiated on 24 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 2E001; Exp. 05/15

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1579-2014
FDA event ID: 68967
Recalling firm: Apotex, Toronto
Classification: Class II
Status: Terminated
Recall initiated: 24 Mar 2014
FDA classified: 3 Sep 2014
Reported: 10 Sep 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Antidepressants

Timeline

24 Mar 2014	Recall initiated by company
3 Sep 2014	Classified by FDA	+163 days
10 Sep 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Product as listed by the FDA

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

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.

Which lots are affected?

Lot # 2E001; Exp. 05/15

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 27 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 68967

This product is part of a recall event; the main page for the event is Paroxetine HCL Controlled-Release Tablets 25 mg recalled by Apotex.

Reported	Class	Recall	Company	Reason	Where
10 Sep 2014	CLASS II	Paroxetine HCL Controlled-Release Tablets 25 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paxil (Paroxetine HCL) Tablets 40 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paxil (Paroxetine HCL) Tablets 10 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paroxetine HCL Controlled-Release Tablets 37.5 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paxil CR (Paroxetine HCL) Controlled-Release Tablets 25 mg recalled	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paxil (Paroxetine HCL) Oral Suspension 10 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paxil (Paroxetine HCL) Tablets 20 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014	CLASS II	Paroxetine HCL Controlled-Release Tablets 12.5 mg recalled by Apotex	Apotex	Other	Nationwide

More recalls from Apotex

All 75

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Drug	CLASS II	Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled	Apotex	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled	Apotex	Other	Nationwide
25 Mar 2026Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine	Apotex	Sterility	Nationwide
8 Oct 2025Drug	CLASS II	Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution	Apotex	Sterility	Nationwide

Other Paxil (paroxetine recalls

All 6

Reported	Class	Recall	Company	Reason	Where
10 Sep 2014Drug	CLASS II	Paxil (Paroxetine HCL) Tablets 20 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paxil (Paroxetine HCL) Oral Suspension 10 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paxil CR (Paroxetine HCL) Controlled-Release Tablets 25 mg recalled	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paxil (Paroxetine HCL) Tablets 10 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paxil (Paroxetine HCL) Tablets 40 mg recalled by Apotex	Apotex	Other	Nationwide