Sunstar Americas, Inc. BUTLER Clear Dip, 12 bottles/case Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BUTLER Clear Dip, 12 bottles/case
Brand
Sunstar Americas, Inc.
Lot Codes / Batch Numbers
SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
Products Sold
SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD
Sunstar Americas, Inc. is recalling BUTLER Clear Dip, 12 bottles/case due to Product lacks premarket clearance.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product lacks premarket clearance.
Recommended Action
Per FDA guidance
A Recall Letter is being sent to all direct consignees who have received impacted product via USPS First Class mail The Recall Letter will be posted to the corporate web site at www.gumbrand.com Customers are instructed as follows: 1. Please examine your inventory to determine if you have any of the affected product lots 2. Please call 1-800-528-8537 or email: us.pcr@us.sunstar.com with the results of your inventory check (even if the affected lots are no longer in inventory), and if affected lots are present, provide the lot numbers, quantities, and a recall contact. 3. Complete the enclosed Return Response Form and mail, FAX or email the completed form as per the instructions provided. 4. The recalling firm will issue a call tag via UPS for any affected inventory to be returned 5. Upon receipt of the call tag return any affected products to the recalling firm 6. Because this recall is being initiated to the dental office level, the recalling firm asks that consignees also notify any parties to which you have further distributed the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026