Apotex Paroxetine Tablets Recall: Failed Impurities May Cause Harm
Apotex recalls 30mg Paroxetine Hydrochloride tablets (NDC 60505-0084-1, 60505-0084-2, 60505-0084-4) due to impurities. These prescription antidepressants may have unsafe chemical levels that could cause harm.
Recall notice
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Contact the company
What happened, in plain English
Apotex is recalling certain 30mg Paroxetine Hydrochloride tablets (prescription antidepressants) because testing found unsafe chemical levels. This could potentially cause harm to users, though the exact risk is not specified in the recall. Read more at govinfonow.com/recall/33014-apotex-paroxetine-tablets-recall-failed-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/33014-apotex-paroxetine-tablets-recall-failed-impurities-may-cause-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0121-2024
Cite this page
“Apotex Paroxetine Tablets Recall: Failed Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33014-apotex-paroxetine-tablets-recall-failed-impurities-may-cause-harm. Based on FDA recall #D-0121-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0121-2024%22&limit=1).
Why it’s dangerous
The tablets failed quality tests for impurities, specifically an unsafe chemical compound called Amadori Glucose adduct. This could potentially cause harm to users, though the exact risk level isn't specified in the recall notice.
Who’s affected
Prescription antidepressant users who have the specific Apotex Paroxetine tablets with the listed NDC numbers. People taking this medication for depression or anxiety are most at risk.
How to tell if you have this one
Check for the specific NDC numbers: 60505-0084-1 (30-count), 60505-0084-2 (100-count), or 60505-0084-4 (1000-count). These are prescription antidepressants sold by Apotex Corp. in the US.
- Brand
Apotex- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide- NDC
60505-0097-1, 60505-0097-9, 60505-0097-2, 60505-0097-4, 60505-0097-7, 60505-0097-5, 60505-0083-1, 60505-0083-9, 60505-0083-2, 60505-0083-4, 60505-0083-0, 60505-0083-5, 60505-0084-1, 60505-0084-9, 60505-0084-2, 60505-0084-4, 60505-0084-5, 60505-0101-1, 60505-0101-9, 60505-0101-2, 60505-0101-4, 60505-0101-5, 60505-0101-7
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0119-2024 | Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.; Lot numbers: a)100 count bottle: RV2376, RV2377; b) 1000 count bottle: RV2379, RV2380; c) 30 count bottle: RV2375; Exp. 08/2024 | 34,392 |
| D-0120-2024 | 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.; Lot numbers: a)100 count bottle: RV2384, RV2385; b) 1000 count bottle: RV2396, RV2397; Exp. 08/2024 | 48,623 |
| D-0121-2024 | Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.; Lot numbers: a)100 count bottle: RV8686; b) 1000 count bottle: RX0119; c) 30 count bottle: RV2254; Exp. 08/2024 | 25,776 |
| D-0122-2024 | Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.; Lot numbers: RV0131, RV2387, RV2389, RW3296, RV2388; Exp. 08/2024 | 4,074 |
What to do — step by step
Check Your Medication
Look for the NDC numbers 60505-0084-1, 60505-0084-2, or 60505-0084-4 on the bottle label to identify affected tablets.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 35 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0121-2024 (November 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0121-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.