Apotex Torsemide Tablets 5mg Recall: CGMP Deviations Risk
Apotex recalls 5mg Torsemide tablets due to manufacturing deviations. This may affect safety in normal use. Check your product details to see if you are affected.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Apotex is recalling 5mg Torsemide tablets because of manufacturing deviations. This could pose a safety risk if the tablets are used as intended. Read more at govinfonow.com/recall/42126-apotex-torsemide-tablets-5mg-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42126-apotex-torsemide-tablets-5mg-recall-cgmp-deviations-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0245-2017
Cite this page
“Apotex Torsemide Tablets 5mg Recall: CGMP Deviations Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42126-apotex-torsemide-tablets-5mg-recall-cgmp-deviations-risk. Based on FDA recall #D-0245-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2017%22&limit=1).
Why it’s dangerous
CGMP deviations mean the tablets may not meet quality standards. This could lead to safety issues if the product is used as intended.
Who’s affected
People with prescriptions for Torsemide tablets from Apotex Corp. in the U.S. are affected. Those using the product for medical purposes are at risk.
How to tell if you have this one
Check for the product name 'Torsemide Tablets, 5 mg 100-count bottle', manufactured by Apotex Inc. in Toronto, Ontario, Canada, with lot number KW8378 and expiration date 05/17.
- Brand
Apotex- Category
Drug
All 2 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
Terminated- Distribution
United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0244-2017 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01; Lot #: KT5981, KT5982, KT5983; Exp. Date 01/17. | 35,819 bottles (358,190,000 tablets) |
| D-0245-2017 | Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01; Lot #: KW8378; Exp. Date 05/17. | 13,179 bottles (1,317,900 tablets) |
What to do — step by step
Check Product Details
Look for the product name, lot number KW8378, and expiration date 05/17 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 5.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0245-2017 (December 14, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0245-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.