CLASS II Drug recall · Reported 12 Dec 2012 · FDA Enforcement Report

Fluorouracil Topical Cream USP, 5% Tube recalled

Taro Pharmaceuticals U is recalling Fluorouracil Topical Cream USP, 5% Tube, distributed nationwide in the US. The recall was initiated on 21 Nov 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.

NDC51672-4118

Quantity recalled39,982 Tubes

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-086-2013
FDA event ID: 63685
Recalling firm: Taro Pharmaceuticals U, Hawthorne, NY
Brand: Fluorouracil
Manufacturer: Sun Pharmaceutical Industries, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2012
FDA classified: 4 Dec 2012
Reported: 12 Dec 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Creams, Ointments & Gels

Timeline

21 Nov 2012	Recall initiated by company
4 Dec 2012	Classified by FDA	+13 days
12 Dec 2012	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

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

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

Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Which lots are affected?

Lot #s: 118903, Exp. March 2013; 119477, 119483, 119743, Exp. May 2013; 119748, June 2013; 110440, Exp. September 2013; 110599, 110602, 110606, 110607, 110949, 110951, 110953, 110954, 110956, 110958, Exp. October 2013; 110962, 110963, 110965, 111659, 111844, Exp. November 2013; 111845, 111846, Exp. December 2013; 112227, 112228, Exp. January 2014.

Where was it sold?

Nationwide and Puerto Rico

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.

More recalls from Taro Pharmaceuticals U

All 36

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19 Jan 2022Drug	CLASS I	Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate	Taro Pharmaceuticals U	Sterility	Nationwide
10 Feb 2021Drug	CLASS II	Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride	Taro Pharmaceuticals U	Manufacturing (CGMP) Deviations	Nationwide
23 Dec 2020Drug	CLASS II	H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB	Taro Pharmaceuticals U	Potency & Assay	Nationwide

Other Fluorouracil recalls

All 12

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Fluorouracil 560 MG / IVP recalled by Infusion Options	Infusion Options	Sterility	NY
21 Aug 2019Drug	CLASS II	Fluorouracil 560 MG / IVP Fluorouracil 3340 MG QS 0.9% NACL recalled	Infusion Options	Sterility	NY
24 Jul 2019Drug	CLASS I	Fluorouracil Injection, USP (50 mg / mL) fill in a vial recalledFluorouracil	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Jul 2015Drug	CLASS II	Fluorouracil 4250mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR
8 Jul 2015Drug	CLASS II	Fluorouracil 4600mg / D5W, Qty recalled by Lincare	Lincare	Sterility	AR