Medicines, 2015
Shortlist up to four to read them side by side.
2,020 medicine recalls FDA’s Enforcement Report published in 2015, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,020of 2,020 medicine recallsshown with your filters
The list
- Medicine recall Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. Class IIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle Labeling: Incorrect or Missing Lot and/or Exp. Class IIIFDA’s classSep 9, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ADRUCIL (fluorouracil injection, USP), 5 g/100 mL Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube Penicillin Cross Contamination and Presence of Foreign Substance. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only Penicillin Cross Contamination and Presence of Foreign Substance. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( Penicillin Cross Contamination and Presence of Foreign Substance. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31) Penicillin Cross Contamination and Presence of Foreign Substance. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer,… 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer,… 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin… 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant,… 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz 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… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz 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… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phentermine Hydrochloride Capsules, USP, 15 mg Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature… Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles Subpotent Drug: Subpotent atorvastatin. Class IIIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Vancomycin 25 mg/mL Opthalmic Solution Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Dexamethasone 24 mg/mL Injectable, 1 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
- Medicine recall Glycerin (v/v) 72% Injection, 25 mL vial Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNew Jersey and New York
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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