Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Take action
Contact the company
📍Recalling firmPremier Dental Products Co1710 Romano Dr · Plymouth Meeting, PA 19462-2822
“Premier Dental Products: Incorrect Expiration Date on Ferric Subsulfate Solution.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31348-premier-dental-products-incorrect-expiration-date-on-ferric-subsulfate-solution. Based on FDA recall #D-0490-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0490-2026%22&limit=1).
The FDA announced on April 14, 2026, that Premier Dental Products Co is recalling Premier and Monsel's Ferric Subsulfate Solution, 8 mL bottles due to labeling errors. The hazard involves an incorrect expiration date printed on the vial itself. This voluntary Class III recall affects 573 cartons distributed nationwide.
How to tell if you have it
Brand: Premier Dental Products
Product: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles
NDC: 48783-112-08
Lot #: 640911253
Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462
The hazard
According to the FDA, the expiration date on the vial has an extra digit, printed as 2709114 instead of the correct 270914 (2027-09-14). The saleable unit box containing 12 bottles has the correct expiration date. Public reports from FDA's FAERS database include 24 adverse-event reports naming this product, with 11 marked serious and one listing a death.
Context
GovInfoNow's records show Premier Dental Products Co had 1 other recall on record since February 27, 2025, involving Premier Solo Diamond burs that may bend due to hardness issues. Other recent recalls of similar products include OurPharma Fentanyl Injection Recall (September 3, 2026), Haleon Parodontax Mouthwash Recall (December 26, 2025), and Kirkman Lidocaine Cream Recall (February 18, 2026).
How to tell if you have this one
Check for vials labeled with expiration date 2709114 instead of 270914 (2027-09-14). The product is sold as 8mL bottles, prescription-only, with lot number 640911253.
Brand
Premier Dental Products
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Verify the expiration date on the vial label: it should read 270914 (2027-09-14) not 2709114.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within 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 15 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0490-2026 (April 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0490-2026 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.