Medicines, 2022
Shortlist up to four to read them side by side.
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 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amber glass bottle Defective container: defect prevents product from dispensing as intended. Class IIFDA’s classJul 6, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 6, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product… Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonazepam Orally Disintegrating Tablets, USP, 0.125mg Failed Tablet/Capsule Specification; oversized tablet found in a bottle Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tretinoin Capsules, 10 mg Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. Class IIFDA’s classJun 29, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liquid Pellets, OTC, Washington… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C, 30C, 200C, 14X, 15X, 16X, 20X,… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15C, 25C, 30C, 13X, 27X, 30X,… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products,… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid Pellets, OTC, Washington… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pellets, Washington Homeopathic… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, OTC, Liquid Pellets, Washington… cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets cGMP deviations Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereVirginia and Wisconsin
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL Lack of assurance of sterility Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL Lack of assurance of sterility Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL Lack of assurance of sterility Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL Lack of assurance of sterility Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL Lack of assurance of sterility Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Zileuton Extended-Release Tablets, 600 mg, 120-count bottle Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D,… Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IStatusCompletedWhereNationwide
- Medicine recall Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims. Class IIFDA’s classJun 22, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2022ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Xiidra (lifitegrast ophthalmic solution) Failed Impurities/Degradation Specifications. Class IIIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Xiidra (lifitegrast ophthalmic solution) 5% Failed Impurities/Degradation Specifications. Class IIIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE Failed Impurities/Degradation Specifications. Class IIIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE Failed Impurities/Degradation Specifications. Class IIIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ethanol for Injection 95%, 67 mL Multi-Dose vial Lack of Assurance of Sterility Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HCl 2%, Niacinamide 2%, Thiamine… Lack of Assurance of Sterility Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing Class IIIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Homeopathic EarAche Drops, 0.33 FL OZ Microbial contamination of non-sterile product. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Homeopathic EarAche Ear Drops, 0.33 FL OZ Microbial contamination of non-sterile product. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Earache Drops, 0.33 FL OZ Microbial contamination of non-sterile product. Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg cGMP deviations: Temperature abuse Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL cGMP deviations: Temperature abuse Class IIFDA’s classJun 15, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 15, 2022ClassClass IIStatusTerminatedWhereNationwide
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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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