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 Amlodipine and Valsartan Tablets, USP 5/320 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 10/320 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 Valsartan Tablets, USP 40 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 Valsartan Tablets, USP 80 mg, 90-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 Valsartan Tablets, USP 160 mg, 90-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 Valsartan Tablets, USP 320 mg, 90-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 Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b)… 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 Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b)… 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 Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b)… 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 Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b)… 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 Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b)… 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 Olmesartan Medoxomil Tablets, 5 mg/40 mg Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach). Class IIIFDA’s classDec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 12, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 12, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 12, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL Failed Stability Specification: out of specification for iron content. Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and… Class IIIFDA’s classDec 5, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 5, 2018ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereWashington
- Medicine recall Quetiapine Tablets USP 400 mg, 100 tablet bottles Presence of Foreign Substance; metal shard found in tablet Class IIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classDec 5, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 5, 2018ClassClass IIStatusOngoingWhereOhio and Puerto Rico
- Medicine recall Clindamycin Phosphate Topical Solution USP, 1% Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities Class IIIFDA’s classDec 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 5, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall IRBESARTAN Tablets, USP 75 mg 90-count bottle CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand Presence of foreign substance: Product found to contain metal particles. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Westminister Irbesartan Tablets, USP, 300mg CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC… CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included… Class IIIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL Labeling: Label mix-up - the label on the product may not match the formula in the bottle. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clopidogrel Tablets, USP, 300 mg, 30 Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing. Class IIFDA’s classNov 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Progesterone SR 100 mg Capsules Labeling Not Elsewhere Classified: Misbranding. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Progesterone SR 200 mg Capsules Labeling Not Elsewhere Classified: Misbranding. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Tadalafil SR 7 mg Capsules Labeling Not Elsewhere Classified: Misbranding. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Tadalafil SR 12 mg Capsules Labeling Not Elsewhere Classified: Misbranding. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Hawaii and Puerto Rico named
- Medicine recall Metoprolol Tartrate Injection, USP 5mg/5mL, vials Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereNew York
- Medicine recall Zero Xtreme Dietary Supplement 30-count capsules Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ERBITUX CETUXIMAB Injection, 200 mg/100 mL Labeling: Missing label; potential for missing primary container label on the vial. Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereAlabama, Arizona, California, Kansas, Louisiana, Mississippi, Ohio, Oregon, Puerto Rico, Tennessee and Texas
- Medicine recall puriton EYE RELIEF DROPS, 0.5 oz Non-Sterility: Product manufactured under non-sterile production conditions. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg Cross Contamination with Other Products Class IIIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles Cross Contamination with Other Products Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles Cross Contamination with Other Products Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles Cross Contamination with Other Products Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles Cross Contamination with Other Products Class IIFDA’s classNov 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 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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