“Apotex Calcitonin Nasal Spray Recall: Glass Splinter Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33711-apotex-calcitonin-nasal-spray-recall-glass-splinter-risk. Based on FDA recall #D-0568-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0568-2023%22&limit=1).
The FDA announced on April 26, 2023, that Apotex Corp. is recalling Calcitonin Salmon Nasal Spray due to the presence of glass splinter particles in the pump ball seat. This defect rendered the pump inoperable for some units.
The recall addresses the presence of foreign substance, specifically glass splinter particles entrapped inside the pump ball seat. This defect rendered the pump inoperable.
Context
GovInfoNow's records show Apotex Corp. has 24 other recalls on record since June 14, 2007. Recent Apotex recalls include a Paroxetine 37.5mg recall on September 23, 2026, due to dissolution failure and a Paxil CR 37.5mg Tablets recall on August 13, 2026, for failed stability testing. Other recent recalls of similar products include Medinatura ReBoost Nasal Spray (December 12, 2025) and Walgreens Saline Nasal Spray with Xylitol (November 12, 2025), both citing microbial contamination risk.
How to tell if you have this one
Check for the product name 'Calcitonin Salmon (synthetic origin) Nasal Spray', 2200 USP units per mL, and lot number TH5645. The product was manufactured by Apotex Corp. in Toronto, Canada.
Brand
Apotex
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, strength, and lot number to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide throughout the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0568-2023 (April 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0568-2023 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.