Medicines, 2022
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1,349 medicine recalls FDA’s Enforcement Report published in 2022, 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.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Oxytocin 30 Units/500 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.4 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.8 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide Injection, 50 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine Chloride Injection, USP, 100 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%)… Superpotent Drug: product complaint for milky blue appearance and consistency, further investigation by the firm found the recalled lots out of specification… Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Pot./HCTZ 100/12.5 mg CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 8, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia and Louisiana
- Medicine recall Losartan Potassium Tablets, USP 25 mg CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP, 50 mg CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Losartan Potassium Tablets, USP, 100 mg CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer With Broad Spectrum SPF… cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall AMBI Skincare Fade Cream Normal Skin cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall AMBI Skincare Fade Cream Oily Skin New & Improved cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment With Oat and Sea Whip cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Aloe Vera, 8 FL cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients cGMP deviations: product stored outside of labeled temperature requirements. Class IIFDA’s classJun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Anagrelide Capsules USP, 0.5 mg, 100-count bottles Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 8, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 8, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Losartan HCTZ 50/12.5 mg, 90 count bottle Original CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Losartan HCTZ 100/25 mg, 90 count bottles CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida, South Carolina and Virginia
- Medicine recall Losartan HCTZ 100/12.5 mg, 90 count bottles CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida, South Carolina and Virginia
- Medicine recall Zonisamide Capsules USP, 100 mg, 90-count bottle CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours Defective Delivery System: customer complaints exceeded respective action limits. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Higher Education Make Out Ready Vegan Lip Balm, SPF 15 Mislabeling: The active ingredient list on the label does not match the product’s actual ingredients Specifically, the label states Octinoxate 7.5% and… Class IIIFDA’s classJun 1, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 1, 2022ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90 CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 1, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30 CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class IIFDA’s classJun 1, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereCalifornia and Florida
- Medicine recall Losartan Pot/HCTZ 100/12.5 mg 90 Tabs CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Losartan Pot/HCTZ 50/12.5 mg 90 Tabs CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Losartan Pot/HCTZ 100/25 mg 90 Tabs CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportFloridathe one state its words name PublishedJun 1, 2022ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle Labeling: incorrect or missing lot and/or expiration date. Class IIIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 1, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Diluent for Reconstitution Multi-Dose 10 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sodium Tetradecyl Sulfate 0.3% Injection, Multi-Dose 30 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Sodium Tetradecyl Sulfate 5% MDV Injection, Multi-Dose 5 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Testosterone Cypionate 200 mg/mL in Sesame Oil Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medicine recall Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial Lack of assurance of sterility. Class IIFDA’s classJun 1, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 1, 2022ClassClass IIStatusCompletedWhereNationwide, and Puerto Rico and US Virgin Islands named
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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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