FDA recall, , Low risk
Premier Monsel's Ferric Subsulfate Solution
Premier Monsel's Ferric Subsulfate Solution has an incorrect expiration date printed on the vial.
Summary by Recall Canary from the FDA notice
What happened
Premier Dental Products Co, of Plymouth Meeting, Pennsylvania, recalled Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, because the expiration date printed on the vial has an extra digit, showing 2709114 instead of the correct 270914 (2027-09-14). The error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed. The recall began on April 14, 2026, and the product was distributed nationwide within the United States.
The product is manufactured by Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462. The recall covers 573 cartons. The FDA added the recall to its Enforcement Report on April 20, 2026, and classified it on April 24, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC or UPC and lot code listed under your product.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles
- NDC
- 48783-112-08
- UPC
- 640911253
- Lot code
- 2709114
Recall details
- Company began the recall
- Sold in
Nationwide within the United States
- Company
- Premier Dental Products CoPlymouth Meeting, Pennsylvania
- Hazard
- Labeling error
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98775
- Recall number
- D-0490-2026
- Quantity recalled
- 573 cartons
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
