CLASS II ONGOING Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report
Paroxetine Hydrochloride Tablets recalled by Apotex
Apotex is recalling Paroxetine Hydrochloride Tablets USP, distributed nationwide in the US. The recall was initiated on 1 Nov 2023 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-0120-2024
- FDA event ID
- 93353
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 27 Nov 2023
- Reported
- 6 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Antidepressants
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 27 Nov 2023 | Classified by FDA | +26 days |
| 6 Dec 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Which lots are affected?
Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024
Where was it sold?
Nationwide
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 1 Oct 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
3 other products · FDA event 93353This product is part of a recall event; the main page for the event is Paroxetine Hydrochloride Tablets recalled by Apotex.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide | |
| CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide | |
| CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Paroxetine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 20 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine tablets, USP, 40 mg, Packaged as a) recalled | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Paroxetine Hydrochloride Tablets recalled by Apotex | Apotex | Potency & Assay | Nationwide |