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 Spearmint 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 Nutralox Peppermint Antacid (Calcium Carbonate 420 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 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 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 Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) 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 Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 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 325 mg (Acetaminophen 325 mg, Pamabrom 25 mg tablet) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Pain Aid PMF Caplet (Acetaminophen 500 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories,… 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 Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 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 DBI Magnums Tablet (Caffeine 200 mg) 100 and 500 count & 3 and 36 count packets & 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 Cystex Tablet (Sodium Salicylate 162.5 mg, Methenamine 162 mg) Bulk Container, ULTRAtab Laboratories, Inc.,… 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 Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall MegMan Performance Booster, 800 mg capsules 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 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HARD DAWN, Rise and Shine capsules, 500 mg Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 16, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 16, 2022ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medroxyprogesterone Acetate Injection, IM, 150 mg/mL Lack of Assurance of Sterility Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cystex Urinary Pan Relief (NSAID) (methenamine 162mg, sodium salicylate 162.5mg tablets) cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DBI 357 Super Magnum Quick Energy Stimulant (caffeine 200mg) tablets cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician’s Seal… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pain Away Pain Reliever/Fever Reducer (NSAID) (acetaminophen 110 mg, aspirin 162 mg, salicylamide 152mg,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SINU-PHEN PLUS sinus pain and congestion tabs (acetaminophen 500 mg, Phenylephrine HCl 5.0 mg) 2 tablet… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass 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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