FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass III · Drug · Recalled April 29, 2026

Premier recall — Premier Dental Products Co

Hazard: 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.

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0490-2026
Brand
Premier Dental Products Co
Classification
Class III
Units affected
573 cartons
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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.

Affected products

Companies & origin

Recalling firm location
Plymouth Meeting, PA, United States
Firm address
1710 Romano Dr, N/A, 19462-2822

Identifying details (verbatim from the notice)

Product codes / lots
Lot #: 640911253, Exp Date. 09/14/2027.
Distribution
Nationwide within the United States
Firm notified the public via
E-Mail
FDA event ID
98775
Recall initiated
April 14, 2026
FDA classified
April 24, 2026
FDA report date
April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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