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Class III · Lower riskActive recall

Monsels Solution

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 640911253, Exp Date. 09/14/2027.
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byPremier Dental Products Company
Brand nameMONSELS SOLUTION
Generic nameFERRIC SUBSULFATE
Active ingredient(s)FERRIC SUBSULFATE
Distributed by / forPremier Dental Products Co
NDC48783-112-08
Show the full FDA record
Full product labelPremier, 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 firmPremier Dental Products Co
DistributionNationwide within the United States
Quantity573 cartons
Recall initiated2026-04-14
Report date2026-04-29
Recall completed—
Recall numberD-0490-2026
ClassificationClass III
FDA statusOngoing
Origin on filePlymouth Meeting PA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.