Medicines, 2022
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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 PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 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 PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 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 CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 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
- Medicine recall Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola 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 & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, 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 Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg)… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PAPENOL (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 MAGNACAL (calcium carbonate 420 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 PEPTIME Energy (caffeine 250mg) tablets, 100-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 PEPTIME Energy (caffeine 300mg) 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 PEPTIME Energy (caffeine 350mg) 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 PEPTIME Energy (caffeine 250mg) 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 CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 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 MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC,… cGMP deviations Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Exaprin pain reliever (acetaminophen 110 mg, aspirin 162 mg, caffeine 32.4mg, salicylamide 152mg) tablets, 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 Nutralox Mint Antacid (calcium carbonate 420mg) Chewable 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 FEM-PRIN MENSTRUAL RELIEF (acetaminophen 325 mg, pamabrom 25mg) 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 CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, 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 CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 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 AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count 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 SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count 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 MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count 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 ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count 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 REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) 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 REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) 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 Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 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 Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 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 Tretinoin Capsules, 10 mg, 100 count bottle Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. Class IIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg Mislabeling Class IIIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg Mislabeling Class IIIFDA’s classFeb 9, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 9, 2022ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Failed Dissolution Specifications. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe,… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for… Lack of Assurance of Sterility. Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per… Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin-C, 40mg/40mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL Lack of Assurance of Sterility Class IIFDA’s classFeb 2, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 2, 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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