Browse Drug Recalls
136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 136 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 136 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2016 | SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC... | Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets. | Class III | Mckesson Packaging Services |
| Mar 25, 2016 | Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle... | Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta... | Class III | Bryant Ranch Prepack Inc. |
| Mar 25, 2016 | CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ... | Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine | Class I | Reliable Rexall-A Compounding Pharmacy |
| Feb 10, 2016 | Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (2... | Labeling: Label Mix-Up | Class III | Pfizer Inc |
| Dec 18, 2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softge... | Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. | Class III | National Vitamin Co Inc |
| May 21, 2015 | SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... | Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... | Class II | Medtech Products, Inc. |
| Apr 28, 2015 | PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0... | Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chlo... | Class II | SCA Pharmaceuticals |
| 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 |
| Mar 31, 2015 | C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC... | Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as... | Class II | Cody Laboratories, Inc. |
| Oct 17, 2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinon... | Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadverten... | Class II | Obagi Medical Products |
| Jul 1, 2014 | Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Jul 1, 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| Feb 14, 2014 | CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals... | Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrullin... | Class I | Medisca Inc |
| Aug 8, 2013 | K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium... | LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... | Class II | Qualitest Pharmaceuticals |
| Aug 8, 2013 | EFFERVESCENT POTASSIUM/CHLORIDE TABLETS, 25 meq Potassium Chloride (1865 mg),... | LABELING: Label Mix-up: 30 count Effervescent Potassium/Chloride Tablets, may be labeled as 30 co... | Class II | Qualitest Pharmaceuticals |
| Jul 25, 2013 | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL... | Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes lab... | Class III | Hi-Tech Pharmacal Co., Inc. |
| Jun 17, 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distribu... | Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 ... | Class I | Advance Pharmaceutical Inc |
| Feb 1, 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescripti... | Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Fre... | Class III | Ferring Pharmaceuticals Inc |
| Aug 23, 2012 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Dist... | Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules." | Class III | Stat Rx USA |
| Jul 25, 2012 | Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, R... | Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly... | Class III | American Health Packaging |
| Jul 23, 2012 | Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , M... | Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (A... | Class III | Stat Rx USA |
| Jul 6, 2012 | NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufact... | Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90... | Class II | Glenmark Generics Inc., USA |
| Jun 28, 2012 | Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 dose... | Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Fact... | Class III | Health Plus Incorporated |
| Jun 18, 2012 | Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only... | Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "oi... | Class III | Stat Rx USA |
| Jun 5, 2012 | Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, M... | Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C ... | Class III | JHP Pharmaceuticals, LLC |
| Apr 26, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)... | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... | Class III | Bayer Healthcare, LLC |
| Apr 26, 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b... | Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... | Class III | Bayer Healthcare, LLC |
| Nov 10, 2010 | Morphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only,... | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfa... | Class I | Physicians Total Care, Inc |
| Nov 10, 2010 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, ... | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfa... | Class I | Physicians Total Care, Inc |
| Mar 1, 2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit car... | Class II | K C Pharmaceuticals Inc |
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.