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 5, 2026.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D… Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas Lack of Assurance of Sterility Class IIFDA’s classNov 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cortaid Intensive Therapy Cooling Spray CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cortaid Maximum Strength Cream CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cortaid 12-Hour Advanced Anti-itch Cream CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial… Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles Defective Container: Repetitive complaints received indicating pump not working. Class IIIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 Incorrect Product Formulation Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox… Lack of Process Controls Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 Lack of Process Controls Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereSouth Carolina
- Medicine recall Cidofovir injection 375 mg/mL Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile Lack of assurance of sterility: loss of container integrity. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paliperidone Extended Release Tablets 3 mg Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Paliperidone Extended Release Tablets 9 mg Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR… Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle Presence of precipitate Class IIIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bumetanide Tablets, USP, 1 mg, 100-count bottle Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Bumetanide Tablets, USP, 2 mg, 100-count bottle Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. Class IIFDA’s classOct 31, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 31, 2018ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical… CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. Class IIIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50 Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CareOne, Saline Nasal Gel With Soothing Aloe CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9% CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol &… CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Saline Nasal Gel with Soothing Aloe CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65% CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65% CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall meijer, Saline Nasal Spray, Nasal Moisturizing Spray CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Meijer, Sterile Saline Nasal Mist CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HuMist Saline Nasal Mist 1.5 FL OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ CGMP Deviations: products manufactured under conditions that could impact its product quality. Class IIFDA’s classOct 24, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2018ClassClass 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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