Medicines, 2019
Shortlist up to four to read them side by side.
2,152 medicine recalls FDA’s Enforcement Report published in 2019, 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.
2,152of 2,152 medicine recallsshown with your filters
The list
- Medicine recall Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial Lack of Processing Controls Class IIFDA’s classAug 7, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereColorado, Texas and Wyoming
- Medicine recall Timolol-Latanoprost P-F Subpotent Drug Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Timolol- Dorzolamide- Latanoprost P-F Subpotent Drug Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton Failed Dissolution Specifications: Out of specification result for the dissolution test. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl Microbial contamination of non-sterile product Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf… Class IIFDA’s classAug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg Failed dissolution specifications : failed results at the 3-month stability time point. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g… CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall Oliver’s Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Oliver’s Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall GENCONTUSS (Chlorpheniramine Maleate, 2mg CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel,… CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall TUSSLIN (Dextromethorphan HBr, 28 mg CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall SORBUGEN NR (Dextromethorphan HBr, 15 mg CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall NEOGEN-D (Dextromethorphan HBr, 30 mg CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, Puerto Rico and Texas named
- Medicine recall Temozolomide Capsules, 5 mg CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 20 mg CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 100 mg CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 140 mg CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 180 mg CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Temozolomide Capsules, 250 mg, 5-count bottle CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container Lack of Assurance of Sterility: Bags have potential to leak. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05)… Failed Dissolution Specifications Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC… Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets Class IIIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg… Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well… Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for… Class IIIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ritussin DM Children & Adults, 4 Fl cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. cGMP Deviations: Products may have microbial contamination. Class IIFDA’s classJul 31, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2019ClassClass IIStatusTerminatedWhereNationwide
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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