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 Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg. Class IIIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall RISE UP RED EDITION Capsules, 650 mg, 10-count blisters Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol. Class IIFDA’s classMar 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Diazepam Oral Solution (Concentrate), 25 mg per 5 mL Failed Impurities/Degradation Specifications: Out of specification results for related substances. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedFeb 23, 2022ClassClass IIStatusOngoingWhereNew York
- Medicine recall Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile Failed Impurities/Degradation Specifications Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MAC DADDY RED Capsules Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MAC DADDY PURPLE Capsules Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 0.25 mg cGMP Deviations Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 0.5 mg cGMP Deviations Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 1.0 mg cGMP Deviations Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP 2.0 mg cGMP Deviations Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pyrazinamide Tablets, USP 500 mg, 100-count bottles cGMP Deviations Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Chlorthalidone Tablets USP 25 mg Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall THE RED PILL, EXTRA STRENGTH capsules, 800 mg Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl PF 10 mg/50 mL Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereColorado, Ohio and Texas
- Medicine recall Morphine Sulfate PF 25 mg/25mL Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereColorado, Ohio and Texas
- Medicine recall RED MAMMOTH capsules, 400 mg Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and… Non-sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial Non-sterility; bacterial contamination identified as Paenibacillus lautus. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Erythromycin Topical Gel USP, 2% Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds. Class IIFDA’s classFeb 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 23, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container,… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall 4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container,… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Coated APAP 325mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland,… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall APAP 500 mg SRC Coated (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container,… CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY CGMP Deviations Class IIFDA’s classFeb 16, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 16, 2022ClassClass IIStatusTerminatedWhereNo state named
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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