Novartis Consumer Health
Complete recall history across all FDA and CPSC categories — 60 total recalls
Recall Summary
Novartis Consumer Health appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Food Recalls (12)
FDA food safety enforcement actions by Novartis Consumer Health
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 18, 2013 | Benefiber fiber supplement stick packs, sugar free and taste free, packaged i... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| Aug 6, 2013 | Benefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100... | The lot number and/or expiration date may be illegible on the outer plastic b... | Class III |
| Aug 6, 2013 | Benefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. F... | The lot number and/or expiration date may be illegible on the outer plastic b... | Class III |
| Aug 6, 2013 | Benefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer H... | The lot number and/or expiration date may be illegible on the outer plastic b... | Class III |
| Aug 6, 2013 | Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar fr... | The lot number and/or expiration date may be illegible on the outer plastic b... | Class III |
| Aug 6, 2013 | Benefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable table... | The lot number and/or expiration date may be illegible on the outer plastic b... | Class III |
| May 7, 2013 | Benefiber Non-Thickening Powder, Sugar Free, packaged in the following config... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| May 7, 2013 | Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sug... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| May 7, 2013 | Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| May 7, 2013 | Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, p... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| May 7, 2013 | Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
| May 7, 2013 | Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. b... | The products are being recalled due to the receipt of a relatively high numbe... | Class II |
Drug Recalls (48)
FDA drug safety enforcement actions by Novartis Consumer Health
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 3, 2013 | Loratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufac... | Failed Tablet/Capsule Specifications: The products are being recalled due to ... | Class III |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and sim... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg,... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, W... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicon... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Aug 6, 2013 | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and algi... | Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or exp... | Class III |
| Jun 18, 2013 | Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, ... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochlori... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and ph... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextro... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HB... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hy... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan ... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 m... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diph... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | Theraflu Severe Cold & Cough powder packets containing Daytime formula (aceta... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 18, 2013 | NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydr... | Presence of Foreign Substance: The products are being recalled because they m... | Class II |
| Jun 6, 2013 | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caf... | Defective container: products are packaged in pouches which may not have been... | Class II |
| Jun 6, 2013 | No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Di... | Defective container: products are packaged in pouches which may not have been... | Class II |
| Jun 6, 2013 | Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen... | Defective container: products are packaged in pouches which may not have been... | Class II |
| Jun 6, 2013 | Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine ... | Defective container: products are packaged in pouches which may not have been... | Class II |
| May 15, 2013 | Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorphen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlor... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextrometho... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 cap... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorph... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| May 15, 2013 | Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen... | Failed Impurities/Degradation:Specifications:Unknown degradant found during s... | Class III |
| Apr 19, 2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tub... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
| Mar 7, 2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or exp... | Class III |
| Mar 7, 2013 | 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hy... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or exp... | Class III |
| Mar 7, 2013 | 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydroc... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or exp... | Class III |
| Mar 7, 2013 | Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. t... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or exp... | Class III |
| Mar 7, 2013 | 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, ... | Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or exp... | Class III |
| Feb 19, 2013 | Target Up & Up, athlete's foot cream, full prescription strength, terbinafine... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
| Feb 19, 2013 | Voltaren Gel (diclofenac sodium topical gel) 1%, for topical use only, RX onl... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
| Feb 19, 2013 | Lamisil AT Cream (terbinafine hydrochloride 1% antifungal), 12 gm ( .42 oz) T... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
| Feb 19, 2013 | Novartis Lamisil AT Cream for Jock Itch (terbinafine hydrochloride 1% antifun... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
| Feb 19, 2013 | Novartis Lamisil AT Cream, Terbinafine Hydrochloride Cream 1% Antifungal, No... | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Exp... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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