Monsels Solution

Ferric Subsulfate · Paste · Topical

Prescription (Rx) Parenteral Iron Replacement Phosphate Binder 1 recall

Dosage and administration

Do not reuse, discard after one use.

Storage

Store at room temperature (15-30degC) Keep cap tightly sealed Protect from light Mfg. for and distrib. by: Gynex North Richland Hills, TX

Label text from the FDA structured product label by Premier Dental Products Company (revised Jan 13, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Monsels Solution NDC products (2)

NDCStrength & formLabelerType
48783-112Ferric Subsulfate 210 mg/g
Paste
Premier Dental Products CompanyUNAPPROVED DRUG OTHER
48783-113Ferric Subsulfate 210 mg/g
Paste
Premier Dental Products CompanyUNAPPROVED DRUG OTHER

Monsels Solution recalls

Frequently asked questions

Who makes Monsels Solution?

Monsels Solution is listed by 1 labeler in the FDA NDC directory, including Premier Dental Products Company.

Has Monsels Solution been recalled?

The FDA enforcement database lists 1 recall for Monsels Solution, most recently D-0490-2026 (class iii): 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).…