Recall of Premier Monsel's Solution Due to Labeling Error
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Premier Dental Products Co. is voluntarily recalling 573 cartons of Monsel's Solution because of an incorrect expiration date on the vials, affecting nationwide distribution in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Premier Dental Products Co. is recalling Monsel's Solution due to a labeling error where the expiration date on the vials is printed as 2709114 instead of the correct 270914, corresponding to September 14, 2027. This error is limited to the vials, while the boxes have the correct date.
Which Products Are Affected
The affected product is Premier Monsel's Ferric Subsulfate Solution in 8 mL bottles, with NDC 48783-112-08 and package NDC 48783-112-08. The recall involves Lot #: 640911253, with the correct expiration date of September 14, 2027. A total of 573 cartons are affected, distributed nationwide within the United States.
What You Should Do
Consumers who have the affected product should check for Lot #: 640911253 and contact Premier Dental Products Co. at 1710 Romano Dr, Plymouth Meeting, PA 19462 for instructions on returns or refunds, as this is a voluntary firm-initiated recall.
Why This Matters
Accurate labeling on medical products is essential to ensure proper use and safety; this recall addresses a potential confusion with expiration dates that could affect product efficacy, though it is classified as a low-risk issue.
Source
This recall information is from the FDA, recall number D-0490-2026. For more details, visit the FDA website or search for event ID 98775.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,317 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.