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 Estradiol Tablets, USP, 2 mg, 100-count bottle Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the… Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportTennesseethe one state its words name PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Fentanyl Citrate 2 mcg per mL Sub-potent Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate 2 mcg per mL Sub-potent Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medicine recall Infants’ Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medicine recall Infants’ Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free,… Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medicine recall Monsel’s (Ferric Subsulfate) Solution, 8 mL amber glass bottle Superpotent Drug: contains higher levels of Iron than labeled. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle Superpotent Drug. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle Labeling: Wrong bar code Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube. Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g… Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Human Chorionic Gonadotropin 3000 IU Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereWashington
- Medicine recall NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups Failed Impurities/Degradation Specifications:Out of specification for impurities. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dyural-40 Injection Kit, 1 Dose, Single Use Only Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Dyural-80 Injection Kit, 1 Dose, Single Use Only Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 26, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 26, 2018ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Nevirapine Extended Release Tablets, 400 mg, 30-count bottle Failed Dissolution Specifications. Class IIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. Class IIIFDA’s classDec 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 26, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit cGMP violations noted during the firm’s most recent inspection. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SHEER DesenZ Desensitizing Treatment cGMP violations noted during the firm’s most recent inspection. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20% cGMP violations noted during the firm’s most recent inspection. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10% cGMP violations noted during the firm’s most recent inspection. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clopidogrel Tablets, USP, 300 mg, 30 Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability… Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Norepinephrine 8 mg Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride Class IIIFDA’s classDec 19, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 19, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Thyroid Powder, USP, 25kg/drum CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminster Irbesartan Tablets, USP 75 mg CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminster Irbesartan Tablets, USP 150 mg CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminster Irbesartan Tablets, USP 300 mg CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets, USP, 80 mg, 90-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets, USP, 160 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets, USP, 40 mg, 30-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan Tablets, USP, 320 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. Class IIFDA’s classDec 19, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 19, 2018ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
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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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