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 6, 2026.
1,349of 1,349 medicine recallsshown with your filters
The list
- Medicine recall CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint,… Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class IIIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Brinzolamide Ophthalmic Suspension, USP 1% Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not… Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Foam, 0.05% CGMP Deviations Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles Failed Stability Specifications Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups Microbial Contamination of Non-Sterile Product FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg,… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant,… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP,… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine… Failed Dissolution Specifications Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg Subpotent drug Class IIIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg,… CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. Class IIFDA’s classJan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen (NDC 49502-0196-71) Labeling: Missing Label: label missing from some Semglee prefilled pens. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 26, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 26, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle Complaint received of foreign matter (metal) embedded in tablet. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and… Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carbamazepine Tablets, USP 200 mg 100 Tablets Failed Dissolution Specifications Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin 750 mg Extended Release CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJan 19, 2022ClassClass IIStatusTerminatedWherePennsylvania
- Medicine recall Morphine Sulfate Oral Solution 100 mg per 5 mL Labeling: Missing Label Class IIIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL Labeling: Missing Label Class IIIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL Lack of Assurance of Sterility Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL Lack of Assurance of Sterility Class IIFDA’s classJan 19, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereMississippi, Ohio and Tennessee
- Medicine recall Norepinephrine Bitartrate Injection USP 4 mg/4 mL Lack of Assurance of Sterility Class IIFDA’s classJan 19, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereMississippi, Ohio and Tennessee
- Medicine recall Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles Defective Delivery System Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobetasol Propionate Ointment USP, 0.05%, 60g tubes Microbial Contamination of Non-Sterile Products: presence of R. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 19, 2022ClassClass IStatusTerminatedWhereNationwide, and Louisiana and Utah named
- Medicine recall Sufentanil Citrate Injection, USP 100 mcg/2 mL Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Class IIFDA’s classJan 19, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 19, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. Class IIIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 12, 2022ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets CGMP Deviations: failed stability results, inadequate laboratory investigations, Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with… Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. Class IIFDA’s classJan 12, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 12, 2022ClassClass IIStatusTerminatedWhereNationwide
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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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