Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only

Premier Dental Products Co has recalled Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 29, 2026 and was initiated on April 14, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, with approximately 573 cartons affected. The company behind the recall is Premier Dental Products Co, based in Plymouth Meeting, PA. The FDA describes the product as: “Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.”

Why was Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only recalled?

According to the FDA, the stated reason for the recall is: “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 expiratio….”

What should you do?

If you think you may have bought Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, compare it against the product description and identifying codes (Lot #: 640911253, Exp Date. 09/14/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Premier Dental Products Co or your local health authority.

About this recall

This recall was distributed in PA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.