Reckitt Benckiser LLC
Complete recall history across all FDA and CPSC categories — 15 total recalls
Recall Summary
Reckitt Benckiser LLC appears in recall records across 3 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.
Drug Recalls (9)
FDA drug safety enforcement actions by Reckitt Benckiser LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 3, 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... | Labeling: Label Error on Declared Strength; label on outer carton incorrectly... | Class III |
| Apr 15, 2015 | Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppres... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class II |
| Apr 15, 2015 | Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Apr 15, 2015 | Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Ma... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Apr 15, 2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Apr 15, 2015 | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Apr 15, 2015 | Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain ... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Apr 15, 2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pai... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labe... | Class I |
| Nov 10, 2014 | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... | Defective container: A customer complaint revealed the presence of a defectiv... | Class III |
Device Recalls (5)
FDA medical device enforcement actions by Reckitt Benckiser LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 19, 2018 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340... | Five batches of the product have failed the specification of 1.0kPa for Burst... | Class II |
| Dec 19, 2018 | Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-987... | Five batches of the product have failed the specification of 1.0kPa for Burst... | Class II |
| Aug 6, 2018 | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene mal... | Product marketed in U.S. does not have sufficient data to ensure that it will... | Class II |
| Jul 23, 2018 | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 0234... | The products failed the filed specification of 1.0kPa for Burst Pressure. | Class II |
| Nov 22, 2016 | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine l... | Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missin... | Class II |
Product Recalls (1)
CPSC consumer product recalls by Reckitt Benckiser LLC
| Date | Product | Hazard |
|---|---|---|
| Mar 20, 2025 | Woolite Delicates detergent in 50-fluid-ounce bottles | The recalled products can contain Pseudomonas species bacteria, including Pseudomonas oleovorans,... |
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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