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 MethylPREDNISolone Tablets, USP 8 mg, 25 tablets CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. Class IIFDA’s classJun 26, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 26, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacteriostatic Water for Injection, 10 mL vials, Pharm D Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg, Depanthenol 5mg) injectable,… Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 10,000 IU vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 5,000 IU vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Human Chorionic Gonadotropin 12,000 IU vials Pharm D Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ipamorelin Acetate 9 mg/9mL Injectable vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg)… Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-2 9 mg/6 mg vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-2 & 6 Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-2 &6 Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sermorelin/GHRP-2 &6 Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone 200 mg/mL, 30 mL vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cyp/Pro 95/5%, 10 mL vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable, 5mL… Lack of Sterility Assurance. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Estradiol Vaginal Inserts USP 10 mcg Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles Failed Dissolution Specifications: Out of specification result for dissolution. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zileuton Extended-Release Tablets, 600 mg, 120-count bottles Failed Dissolution Specifications: Out of specification result for dissolution. Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 25,000 USP units per 250 mL Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin… Class IIFDA’s classJun 19, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 19, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 19, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 19, 2019ClassClass IStatusTerminatedWhereMichigan and Ohio
- 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 Children’s Acetaminophen Liquid, 160 mg per 5 mL, Fever and Pain, Alcohol free, aspirin free, ibuprofen free,… 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 Allergy Liquid Antihistamine, Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 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 Children’s Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry… 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 Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 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 Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One… 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 Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 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 Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful… 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 Pseudoephedrine Oral Solution, 30 mg in each teaspoonful, Nasal Decongestant, One Pint 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 Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 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 Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant… 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 Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant, nasal decongestant,… 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 Biscolax Laxative (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 Cyproheptadine Hydrochloride Syrup Oral Solution, USP, 2mg/5mL, 473 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 Hyoscyamine Oral Drops 0.125 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 Hyoscyamine Sulfate Elixir 0.125 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 Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD 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 Acetic Acid Otic Solution, USP, 2% 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 Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One… 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 Guaifenesin DAC Oral Solution, Sugar free, (Guaifenesin, Pseudoephedrine HCl and Codeine Phosphate Oral… 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 Phenobarbital Oral Solution, USP, 20 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 Pain & Fever Oral Solution (Acetaminophen 160 mg/5 mL), Sugar free, Aspirin & Alcohol free, Cherry flavored,… 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 Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored,… 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 Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint 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
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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