safco SensiCaine-Ultra (20% Benzocaine) recall
FDA recall D-0606-2026 · initiated May 21, 2026
Keystone Industries recalled safco SensiCaine-Ultra (20% Benzocaine) in May 2026 — an FDA Class II recall (D-0606-2026) because Defective container:may contain bottles with incomplete seals.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container:may contain bottles with incomplete seals
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 150 units
Details
- Product
- safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
- Recalling company
- Keystone Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 21, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was safco SensiCaine-Ultra (20% Benzocaine) recalled?
- Keystone Industries recalled safco SensiCaine-Ultra (20% Benzocaine) in May 2026 — an FDA Class II recall (D-0606-2026) because Defective container:may contain bottles with incomplete seals. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was safco SensiCaine-Ultra (20% Benzocaine) recalled?
- Per the FDA enforcement record, the reason for recall D-0606-2026 was: Defective container:may contain bottles with incomplete seals
- Is a recalled safco SensiCaine-Ultra (20% Benzocaine) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of safco SensiCaine-Ultra (20% Benzocaine) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — BNZ-001921, Exp 04/15/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0606-2026.