Medicines, 2017
Shortlist up to four to read them side by side.
1,073 medicine recalls FDA’s Enforcement Report published in 2017, 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 5, 2026.
1,073of 1,073 medicine recallsshown with your filters
The list
- Medicine recall Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Fluphenazine Decanoate Injection, USP Subpotent Drug Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle Superpotent Drug: An oversized tablet was found in a bottle. Class IIFDA’s classApr 12, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 12, 2017ClassClass IIStatusTerminatedWhereIllinois and New Jersey
- Medicine recall RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine. Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD Failed Impurities/Degradation Specifications; Impurity A Class IIIFDA’s classApr 12, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 12, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ciprofloxacin in Dextrose Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluconazole Injection, USP, 400 mg Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Injection Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metronidazole Injection, USP, 500 mg/100 mL Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination… Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC… Failed Dissolution Specifications; 9 month long term stability Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, 10 mg* Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 20 mg* Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 40 mg* Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 80 mg* Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Montelukast sodium tablets, 10 mg, 30-count bottle Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle. Class IIIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli oil resulting in complaints of off flavor/scent Class IIFDA’s classApr 5, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10% Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue. Class IIIFDA’s classMar 29, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMar 29, 2017ClassClass IIIStatusTerminatedWherePuerto Rico
- Medicine recall ATENOLOL Tablets, USP, 50 mg Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ATENOLOL Tablets, USP, 50 mg, 30-count bottle Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Indiana and Tennessee named
- Medicine recall Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Class IIIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Class IIIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius. Class IIIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Famciclovir tablets, 500 mg Failed impurities/ degradation specifications: Product was above specification for unknown impurities. Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only Presence of Particulate Matter Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Desonide Ointment, 0.05% Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream Class IIFDA’s classMar 29, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point. Class IIIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles Failed Impurities/Degradation Specifications Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free CGMP Deviations Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin Phosphate Topical Solution USP, 1% CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class IIIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC… Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula,… Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel. Class IIIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARIDIN/PODOPHYLLUM RESIN MIXTURE Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG and HCG with resveratrol Human Chorionic Gonadotropin in different strengths: HCG 300 UNITS/RESVERATROL… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2% Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5% CREAM, FLUOROURACIL 4.9% IN… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.025, Synergy RX, 4901 Morena… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BICARBONATE 10% Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2,5% GEL, AZELAIC ACID 15% CREAM,… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2% Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT 20% 8% 4% OINTMENT, BLT 20% 8%… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN… Lack of Assurance of Sterility: There are also CGMP Deviations. Class IIFDA’s classMar 22, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2017ClassClass IIStatusTerminatedWhereNationwide
Nothing matches all of these.
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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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