CLASS III ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Premier, Monsel's, Ferric Subsulfate Solution recalled
Premier Dental Products is recalling Premier, Monsel's, Ferric Subsulfate Solution, distributed nationwide in the US. The recall was initiated on 14 Apr 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0490-2026
- FDA event ID
- 98775
- Recalling firm
- Premier Dental Products, Plymouth Meeting, PA
- Brand
- Monsels Solution
- Manufacturer
- Premier Dental Products Company
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 14 Apr 2026
- FDA classified
- 24 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 14 Apr 2026 | Recall initiated by company | |
| 24 Apr 2026 | Classified by FDA | +10 days |
| 29 Apr 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Premier, Monsel's, Ferric Subsulfate Solution recalled?
Yes. Premier Dental Products recalled Premier, Monsel's, Ferric Subsulfate Solution on 14 Apr 2026. The recall is Class III and its status is Ongoing. Recall number D-0490-2026.
Why was it 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.
Which lots are affected?
Lot #: 640911253, Exp Date. 09/14/2027.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Premier Dental Products
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Premier Solo Diamond - Large Invented Cone recalled | Premier Dental Products | Other | Nationwide |