Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 2, 2013 (14 years ago)

Cetacaine Liquid Topical Anesthetic

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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.

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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 -

Affected NDCs 10223-0202-02 10223-0202-03 10223-0202-04

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Cetacaine Anesthetic
Benzocaine, Butamben, and Tetracaine Hydrochloride
NDC 10223-0202
BENZOCAINE .028 g/.2g; BUTAMBEN .004 g/.2g; TETRACAINE HYDROCHLORIDE .004 g/.2g Solution
Topical
Cetylite Industries, Inc. Rx
Recalling firm
Cetylite Industries, Inc.
NDC code
10223-0202-2
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-019-2014 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other wrong potency / content recalls from 2013

All wrong potency / content recalls
Class II · Moderate risk

Clonazepam Tablets

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Terminated Wrong potency / content Actavis Elizabeth LLC NDC 0228-3005-11 D-1087-2014