How serious is this recall?

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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.) and recall number D-0490-2026, then follow Premier Dental Products Co's recall instructions.

Has Premier Dental Products Co had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Premier Dental Products Co so far. Argus ingests new FDA enforcement records daily.

Recall Record: Class III Recall: MONSELS SOLUTION by Premier Dental Products Co

Here's the summary: Premier Dental Products Co recalled 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. on 2026-04-29. FDA classified this action as a Class III recall (recall number D-0490-2026). 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.. Recall status: Ongoing. This is a drug-category FDA recall record.

Key facts

Recalling firm	Premier Dental Products Co
Manufacturer	Premier Dental Products Company
Brand name	MONSELS SOLUTION
Product description	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.
Classification	Class III
Recall number	D-0490-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
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.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Premier Dental Products Co and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number D-0490-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with 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. -- and the recall number D-0490-2026. If it matches, stop using or distributing it and contact Premier Dental Products Co or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Premier Dental Products Co’s FDA history

Argus HQ has recorded 1 total FDA action tied to Premier Dental Products Co: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What should someone who has this product do?: Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (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.) and recall number D-0490-2026, then follow Premier Dental Products Co's recall instructions.
Has Premier Dental Products Co had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for Premier Dental Products Co so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number D-0490-2026.

Know if this happens again — we'll email you.

Free. No spam, just recall alerts for what you tell us to watch.

Full FDA history for Premier Dental Products Co

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class III Recall: MONSELS SOLUTION by Premier Dental Products Co. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-premier-dental-products-co-d-0490-2026

MLA

"Recall Record: Class III Recall: MONSELS SOLUTION by Premier Dental Products Co." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-premier-dental-products-co-d-0490-2026.

Chicago

Argus HQ Research. "Recall Record: Class III Recall: MONSELS SOLUTION by Premier Dental Products Co." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-premier-dental-products-co-d-0490-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_premier_dental_products_co_d_0490_2026_2026,
  title = {Recall Record: Class III Recall: MONSELS SOLUTION by Premier Dental Products Co},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-premier-dental-products-co-d-0490-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗