Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premie… recall
FDA recall D-0490-2026 · initiated Apr 14, 2026
Premier Dental Products Co recalled Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… in Apr 2026 — an FDA Class III recall (D-0490-2026) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
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.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 573 cartons
Details
- Product
- 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.
- Recalling company
- Premier Dental Products Co
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 14, 2026
- FDA report date
- Apr 29, 2026
Frequently asked
- Was Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… recalled?
- Premier Dental Products Co recalled Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… in Apr 2026 — an FDA Class III recall (D-0490-2026) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… recalled?
- Per the FDA enforcement record, the reason for recall D-0490-2026 was: 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.
- Is a recalled Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur… are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 640911253, Exp Date. 09/14/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0490-2026.