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 5, 2026.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall Nifedipine WSP 0.2% Ointment, 60 gram tubes Subpotent and Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 3, 2022ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of… FAILED DISSOLUTION SPECIFICATIONS Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of… FAILED DISSOLUTION SPECIFICATIONS Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Gel 1% Superpotent Drug: Out of specification assay result was obtained during stability testing. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride Labeling: Missing label: the product tube was missing a label and contained a different formulation. Class IIIFDA’s classAug 3, 2022in FDA’s Enforcement ReportWashingtonthe one state its words name PublishedAug 3, 2022ClassClass IIIStatusCompletedWhereWashington
- Medicine recall Divalproex Sodium Delayed-Release Tablets, USP 500mg Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC… Labeling: Missing label: Label missing from some prefilled pens. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Tablets, USP, 150mg, 90- count bottles Failed dissolution specifications. Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irbesartan Tablets, USP, 75 mg, 90- count bottle Failed Dissolution Specifications Class IIFDA’s classAug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres Failed Dissolution Specifications Class IIIFDA’s classAug 3, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 3, 2022ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres Failed Dissolution Specifications Class IIIFDA’s classAug 3, 2022in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedAug 3, 2022ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall Propofol Injectable Emulsion, 1 g/100 mL Presence of particulate matter: particulate identified as a beetle. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 3, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 3, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol. Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Amino Acid Injection 50 g/1000 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate Injection, USP 1.2 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Buffered Lidocaine HCl (buffered Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCl 150 mg Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine Injection, USP, 0.1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPINEPHrine Injection, USP, 1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Injection, USP, 1 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate Injection, USP, 0.6 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP, 10 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP, 6 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP 30 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP, 50 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine HCl Injection, USP, 50 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine HCl Injection, USP 30 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine HCl Injection, USP, 50 mg/1 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Labetalol HCl Injection, USP, 20 mg/4 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl Injection, USP 2%, 100 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl Injection, USP 1%, 50 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Injection, USP, 50 mg/50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Injection, USP, 30 mg/30 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Injection, USP, 2 mg/2 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Injection, USP, 1 mg/mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall del Nido Cardioplegia Solution 1000 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxytocin 30 Units/500 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.4 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 0.8 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Injection, USP, 1 mg/10 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Bromide Injection, 50 mg/5 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ropivacaine HCl 123 mg Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL Lack of Assurance of Sterility Class IIFDA’s classJul 27, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2022ClassClass 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.
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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