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 Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz Defective container: Customer complaints for oral solution leaking from bottles. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate… Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it… Class IIIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for… Class IIIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chlorhexidine Gluconate Oral Rinse USP 0.12% cGMP deviations: The firm was notified of the manufacturer’s expanded recall. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl cGMP deviations: Product made at the same facility where product tested was sub-potent. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 20, 2021ClassClass IIStatusOngoingWhereTexas
- Medicine recall Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL cGMP deviations: Product made at the same facility where product tested was sub-potent. Class IIFDA’s classJan 20, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJan 20, 2021ClassClass IIStatusOngoingWhereTexas
- Medicine recall Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups Presence of Foreign Substance: Particulate matter was found in multiple lots of product. Class IIIFDA’s classJan 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cephalexin for Oral Suspension, USP, 125 mg per 5 mL Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125… Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate Injection, 0.8 mg/2 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Buffered Lidocaine HCl, 1%, 5 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate, 50 mg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine Sulfate 50 mg/10mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Esmolol HCl 100 mg/10 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 1500 mcg/30 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Glycopyrrolate 1 mg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 6 mg/30mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 30 mg/30 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine 100 mg/10mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall labetalol HCl 20 mg/4 mL, Injection for Intravenous Use Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 1% 10 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl 2% 5 mL, 20 mg/mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 3 mg/3 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall morphine sulfate 150 mg/30 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall neostigmine methylsulfate 5 mg/5 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 1000 mcg/10 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 800 mcg/10 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Br 100 mg/10mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sodium Citrate 4% 3 mL Anticoagulation Solution Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCccinylcholine Chloride 200 mg/10 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate 30 mg/30 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 500 mcg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Rocuronium Br 50 mg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SUCcinylcholine Chloride 100 mg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ePHEDrine 25 mg/5 mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 10mg/50mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine 50 mg/5mL Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit Class IIFDA’s classJan 13, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 13, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospital/Office Use Only Labelling: Missing label. Class IIIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone - Moxifloxacin PF Injection Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Failed Impurity/Degradation Specifications Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Failed Impurity/Degradation Specifications Class IIFDA’s classJan 6, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 6, 2021ClassClass 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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