Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Q.Care Oral Cleansing & Suctioning System q8 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Skin antisepsis and oral cleansing Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles Labeling: Not Elsewhere Classified: does not have the required “CII” controlled drug classification indication on the primary label. Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL… Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Famciclovir Tablets, 500 mg, 30-count bottles Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high… Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct. Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Azelastine HCl Nasal Solution (Nasal Spray) 0.1% Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet… Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl CGMP Deviations: not manufactured according to current good manufacturing practices. Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereFlorida, New York, South Carolina and Washington
- Medicine recall 0.2% Ropivacaine HCI (Preservative Free) Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereFlorida, New York, South Carolina and Washington
- Medicine recall 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereFlorida, New York, South Carolina and Washington
- Medicine recall Fluoxetine Tablets USP, 10 mg, 30-count bottle Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. Class IIIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Aripiprazole Tablets, USP, 10 mg, 100 Tablets CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereSouth Carolina and Tennessee
- Medicine recall Ciclopirox Olamine Cream USP, 0.77% Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration. Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed… Lack of sterility assurance. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed… Lack of sterility assurance. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution… Lack of sterility assurance. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution… Lack of sterility assurance. Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Relumins Vitamin C Solvent ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tatiomax Gluatathione Whitening kits, 1400mg vials Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l. Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Laennec INJ, Placenta extract (human), 2mL vials Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Reiki Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TP Drug Laboratories Vitamin C ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sterilized water for injections BP, 50 x 5 mL plastic ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ling Zhi capsules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Saluta Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit… Class IIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Linezolid Injection 600 mg/300 mL Presence of Particulate Matter; white particulate matter identified as mold was found in one bag FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 14, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL Subpotent Drug: Out of specification for assay (stability testing) Class IIIFDA’s classFeb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 14, 2018ClassClass IStatusTerminatedWhereNationwide
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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