Taro Recalls Fluorouracil Topical Cream Due to Stability Issues
Taro Pharmaceuticals recalls Fluorouracil Topical Cream USP, 5% due to out-of-specification assay and description results in retain samples.
Use caution until it’s fixed
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Contact the company
What happened, in plain English
Taro Pharmaceuticals U.S.A., Inc. is recalling Fluorouracil Topical Cream USP, 5% because the product lacks stability. Out-of-specification results were observed for assay and description in retain samples. The recall affects 39,982 tubes distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/48475-taro-pharmaceuticals-u-s-a-inc-recalls-fluorouracil-topical-cream.
Source Summary by GovInfoNow · govinfonow.com/recall/48475-taro-pharmaceuticals-u-s-a-inc-recalls-fluorouracil-topical-cream · Updated October 13, 2026 · FDA enforcement record: FDA #D-086-2013
Cite this page
“Taro Recalls Fluorouracil Topical Cream Due to Stability Issues.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48475-taro-pharmaceuticals-u-s-a-inc-recalls-fluorouracil-topical-cream. Based on FDA recall #D-086-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-086-2013%22&limit=1).
Why it’s dangerous
The hazard is that the cream has out-of-specification results for assay and description in retain samples, meaning it lacks stability. This implies the active ingredient strength or physical properties may be inconsistent, potentially affecting its efficacy or safety profile.
Who’s affected
Patients who have been prescribed or possess Fluorouracil Topical Cream USP, 5% from Taro Pharmaceuticals with the specific lot numbers listed. Individuals using these specific expired or potentially unstable batches are at risk of receiving a product that does not meet quality standards.
How to tell if you have this one
Check if you have Fluorouracil Topical Cream USP, 5% in a 40 g tube distributed by Taro Pharmaceuticals U.S.A., Inc. Look for NDC 51672-4118-6 and one of the following lot numbers: 118903 (Exp. March 2013); 119477, 119483, 119743 (Exp. May 2013); 119748 (Exp. 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); or 112227, 112228 (Exp. January 2014).
- Brand
Taro Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Lot Number
Verify if your tube matches the recalled lot numbers and expiration dates listed in the record.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine if you should stop using the product or obtain a replacement, as no specific remedy is stated in the record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-086-2013 (November 21, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-086-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.