CLASS II Drug recall · Reported 4 Dec 2013 · FDA Enforcement Report
Cetacaine Liquid Topical Anesthetic recalled by Cetylite Industries
Cetylite Industries is recalling Cetacaine Liquid Topical Anesthetic, distributed nationwide in the US. The recall was initiated on 2 Apr 2013 and the FDA has classified it as Class II.
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-019-2014
- FDA event ID
- 66012
- Recalling firm
- Cetylite Industries, Pennsauken, NJ
- Brand
- Cetacaine Anesthetic
- Manufacturer
- Cetylite Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Apr 2013
- FDA classified
- 26 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Apr 2013 | Recall initiated by company | |
| 26 Nov 2013 | Classified by FDA | +238 days |
| 4 Dec 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Cetacaine Liquid Topical Anesthetic, Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110 -
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point.
Which lots are affected?
Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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 |