Premier — Class III drug recall D-0490-2026
Ongoing recall by Premier Dental Products Co, reported 2026-04-29, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 27
| Recall number | D-0490-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Premier Dental Products Co, Plymouth Meeting, PA, United States |
| Recall initiated | 2026-04-14 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 573 cartons |
| Reason classes | labeling |
| NDC | 48783-0112, 48783-0112-08 |
| Lot numbers | 640911253 |
| Expiration dates | 2027-09-14 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0490-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.