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 Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nasal Decongestant Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactulose Solution, USP 10 g/15 mL, For Oral Administration cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Memantine Hydrochloride Oral Solution, 2 mg/mL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Acetate Suppositories, 25 mg cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hemorrhoidal Suppositories (Phenylephrine HCl 0.25% cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25% cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RisperiDONE Oral Solution, USP, 1 mg/mL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bisacodyl Suppositories, Brite Stock, Reese. cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial Failed Impurities/Degradation Specifications. Class IIIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free,… Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2019in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedJun 19, 2019ClassClass IStatusTerminatedWherePuerto Rico
- Medicine recall Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile Failed Stability Specifications: Out of specification for viscosity. Class IIIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes,… Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes,… Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc. Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature,… Lack of Processing Controls. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sevoflurane, USP Inhalation Anesthetic 250 mL bottles Failed Stability Specifications Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Senna (sennosides 8.8 mg) Syrup, 8 fl oz. Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Senna (sennosides 8.8 mg) Syrup 8 fl oz. Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bevacizumab 2.5 mg/0.1 mL Lack of assurance of sterility Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w) CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62% CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC… CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per… CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin… CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X. CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70% CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml… CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive… CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle Complaint received of metal piece identified in the product bottle prior to the reconstitution. Class IIFDA’s classJun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall The Beast, The Beast can be taken under the situation of Heart disease and even after drinking, 4600 mg X 4… Marketed without an Approved NDA/ANDA: The Beast contains undeclared sildenafil which was discovered through FDA analysis. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 5, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 5, 2019ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets USP 25 mg 30 count bottle CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, Pennsylvania, Tennessee and Texas
- Medicine recall Losartan Potassium Tablets USP 25 mg 90 count bottle CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily… Class IIFDA’s classMay 29, 2019in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 29, 2019ClassClass IIStatusTerminatedWhereIllinois, Michigan, Minnesota, Pennsylvania, Tennessee and Texas
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.”
Your shortlist0 of 4
Add one more to compare.