CLASS I Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic recalled
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare is recalling Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0236-2024
- FDA event ID
- 93691
- Recalling firm
- Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare, Tarrytown, NY
- Brand
- Americaine
- Manufacturer
- Insight Pharmaceuticals LLC
- Classification
- Class I
- Status
- Completed
- Recall initiated
- 21 Dec 2023
- FDA classified
- 17 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Benzene
- Drug class
- Creams, Ointments & Gels
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +27 days |
| 24 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: presence of benzene
Product as listed by the FDA
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Chemical Contamination: presence of benzene
Which lots are affected?
Lot # 1A16420, exp. date 01/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid recalled | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare | Benzene | Nationwide |
Other Benzocaine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |