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 7, 2026.
2,152of 2,152 medicine recallsshown with your filters
The list
- 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 than amount labeled. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- 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 than amount labeled. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000… Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. Class IIIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania and Texas
- Medicine recall MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella… Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania and Texas
- Medicine recall MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella… Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania and Texas
- Medicine recall MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty… Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report13 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania and Texas
- Medicine recall Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg/50 mcg per spray, 120… Defective Container: Potential for broken glass in the neck area of the glass bottles. Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bimatoprost Ophthalmic Solution 0.03% Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities. Class IIIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed,… Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 13, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Irbesartan Tablets 300 mg 90 count CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx 30 Tablets Only CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10 Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Progesterone 10% cream, 12gm to 30gm per prescription Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Testosterone 0.1% cream, 30 grams Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Progesterone 100 mg SR capsules, 30-180 capsules per prescription Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall Domperidone 10 mg capsules, 100-count per prescription Lack of Processing Controls. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportTennesseethe one state its words name PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin for Oral Suspension USP 250mg/5 mL CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging… Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fexofenadine HCl Tablets, USP, 180 mg Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification. Class IIFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 6, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall curaplex Epi Safe Kit, 8600-01101, contains:” 1ml Vial of Epinephrine “ 1 Epi-Safe Syringe “ 1 Safety Needle… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc… Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5K Premium Enhancement capsule, 5000 mg, 1 count blister card, box of 30, Happy Together Inc., Boynton, FL Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 30, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 30, 2019ClassClass IStatusTerminatedWhereNo state named
- Medicine recall Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles Presence of Foreign Substance: Product complaint of black speckles observed on tablets. Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. Class IIIFDA’s classJan 30, 2019in FDA’s Enforcement ReportOhiothe one state its words name PublishedJan 30, 2019ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall HEPERAIN 50 mg/50 mL Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate concentration as… Class IIFDA’s classJan 30, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 30, 2019ClassClass IIStatusTerminatedWhereTexas and Washington
- Medicine recall Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Valsartan tablets USP 320 mg, 90-count bottles CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim… Class IIFDA’s classJan 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2019ClassClass IIStatusOngoingWhereNationwide
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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