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Reckitt Benckiser Recalls
15 recalls on record · May 8, 2013 to March 20, 2019 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 20, 2019Medical DevicesFDA
Reckitt Benckiser LLC recalls Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 0234
Hazard: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
March 20, 2019Medical DevicesFDA
Reckitt Benckiser LLC recalls Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14
Hazard: Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.
October 17, 2018Medical DevicesFDA
Reckitt Benckiser LLC recalls Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for
Hazard: Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
October 3, 2018Medical DevicesFDA
Reckitt Benckiser LLC recalls Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Us
Hazard: The products failed the filed specification of 1.0kPa for Burst Pressure.
March 1, 2017Medical DevicesFDA
Reckitt Benckiser LLC recalls Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubric
Hazard: Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.
September 28, 2016DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 6382
Hazard: Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydramine 25 mg instead of 12.5 mg. Also, quantity is incorrectly stated as 30 daytime and 30 nighttime instead of 36 daytime and 24 nighttime.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bott
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expect
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phe
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
September 2, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan
Hazard: Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
April 29, 2015DrugsFDA
Reckitt Benckiser LLC recalls Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-release bi-layer tablets, 2 tablets per pouch (ND
Hazard: Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
May 8, 2013DrugsFDA
Reckitt Benckiser Inc recalls Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Si
Hazard: Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.