CLASS II Drug recall · Reported 10 Sep 2014 · FDA Enforcement Report
Paroxetine HCL Controlled-Release Tablets 5 mg recalled by Apotex
Apotex is recalling Paroxetine HCL Controlled-Release Tablets 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
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-1577-2014
- FDA event ID
- 68967
- Recalling firm
- Apotex, Toronto
- Manufacturer
- Apotex Corp
- 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
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 60505-3675-3
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Paroxetine HCL Controlled-Release Tablets 5 mg recalled?
Yes. Apotex recalled Paroxetine HCL Controlled-Release Tablets 5 mg on 24 Mar 2014. The recall is Class II and its status is Terminated. Recall number D-1577-2014.
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 # 2C002, Exp. 03/15 Lot # 2H004, Exp. 08/15 Lot # 2H006, Exp. 08/15
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalledParoxetine | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine | Apotex | Potency & Assay | Nationwide |