Novartis Recalls Nupercainal Ointment Due to Illegible Labeling
Novartis Consumer Health is recalling Nupercainal Ointment because lot numbers and expiration dates may be illegible or missing.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to packaging and labeling defects.
Plain-English summary
Novartis Consumer Health is recalling Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment in 1-oz. and 2-oz. tubes. The recall is due to labeling issues where the lot number and/or expiration date may be illegible or missing.
The affected products are distributed nationwide and in Panama. The recall includes specific lot numbers with expiration dates ranging from March 2013 to September 2013.
Consumers should check their products for the affected lot numbers and expiration dates. If the labels are illegible or missing, consumers should stop using the product and contact Novartis Consumer Health for instructions.
The recalled product
- Product
- Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Topical Analgesic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lot #: a) 10109149
- 10111499
- 10117160
- 10119603
- and 10121763
- Exp 4/13 to 8/13
- b) 10109148
- 10112258
- 10113806
- 10115615
- 10117161
- 10119604
- 10119605
- 10121782
- and 10122762
- Exp 3/13 to 9/13.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Novartis Consumer Health
See all →- ModerateNovartis Recalls Benefiber Fiber Supplement Stick Packs Due to Consumer Complaints
FDA (Food) · 2014-03-05
- ModerateNovartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances
FDA (Drugs) · 2014-01-29
- HighNovartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
- ModerateNovartis Recalls Theraflu Exte Powder Packets Due to Foreign Substances
FDA (Drugs) · 2014-01-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowNovartis Lamisil AT Cream Recalled for Illegible Lot and Expiration Dates
FDA (Drugs) · 2013-06-12
- LowNovartis Recalls Lamisil AT Cream Due to Illegible Labeling
FDA (Drugs) · 2013-06-12
- LowNovartis Recalls Lamisil AT Antifungal Cream Due to Illegible Labeling
FDA (Drugs) · 2013-05-29
- ModerateOTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date
FDA (Drugs) · 2023-03-15
- LowNovartis Recalls Benefiber Fiber Supplement Due to Illegible Packaging Labels
FDA (Food) · 2013-09-25
- LowNovartis Recalls Voltaren Gel Due to Illegible Lot and Expiration Dates
FDA (Drugs) · 2013-06-12