Medicines, 2021
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1,016 medicine recalls FDA’s Enforcement Report published in 2021, 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.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Sodium Phenylbutyrate POWDER, 250 grams bottle Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Non-Sterility: firm’s third party lab confirmed microbial contamination. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Sodium Bicarbonate Lack of Assurance of Sterility Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Erythromycin Topical Solution USP, 2%, 60mL bottle Defective container: possibility for lack of seal integrity. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Miss Slim, capsules Marketed without ANDA/NDA approval Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bleomycin for Injection, USP Labeling: Not elsewhere classified: Mislabeling Class IIIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle Temperature abuse: the firm received customer complaints of unusual grittiness in the product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly Failed Stability Specifications; out of specification for shear. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Failed Stability Specifications; out of specification for shear. Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall GaviLyteTM - C PEG-3350 Failed Stability Specification; Out of specification for Osmolarity Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle Marketed Without an Approved NDA/ANDA Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Avicel, Mirocrystalline cellulose Out of specification results for conductivity. Class IIIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle cGMP deviations: Discolored acetaminophen Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Haloperidol Decanoate Injection 100 mg/mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Amikacin Sulfate Injection USP 1 gram/4mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Vecuronium Bromide for Injection 10 mg, 10mL vial Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Adenosine Injection, USP, 60mg/20mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Metoclopramide Injection USP, 10 mg/2mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC… Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Adenosine Injection, USP, 60mg/20 mL Lack of Assurance of Sterility Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tizanidine HCl Tablets, USP 4 mg, 150-count bottles Failed Tablet/Capsule Specification: Some tablets are shaved Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Econazole Nitrate Cream 1%, 85 grams bulk shippers Correct Labeled Product Mispack Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons Correct Labeled Product Mispack Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Carvedilol Tablets, USP 25 mg, 500 Tablets bottles Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle Class IIFDA’s classAug 25, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 25, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Venlafaxine Tablets, USP 50 mg*, 100 Tablets Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportTennesseethe one state its words name PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereTennessee
- Medicine recall BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a)… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a)… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a)… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths,… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b)… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
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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