Browse Drug Recalls
9 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 9 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 9 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 states Diphenhydram... | Class III | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class II | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Apr 15, 2015 | Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorpha... | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| 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 labeled on the front of ... | Class I | Reckitt Benckiser LLC |
| Nov 10, 2014 | Mucinex DM (guaifenesin 600mg and dextromethorphan HBr 30mg), extended-releas... | Defective container: A customer complaint revealed the presence of a defective seal on the top of... | Class III | Reckitt Benckiser LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.