Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall Ketamine HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketoconazole USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketoprofen USP (Micronized) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leucovorin Calcium USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levocetirizine Dihydrochloride for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Hemihydrate USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Levothyroxine Sodium USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lincomycin HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Liothyronine Sodium USP for prescription compounding ,1g CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naltrexone HCl USP (Dihydrate) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nandrolone Decanoate USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nifedipine USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxandrolone USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Pentoxifylline USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phentolamine Mesylate USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prilocaine HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Progesterone USP (Micronized) (Yam) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sildenafil Citrate USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Stanozolol USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sumatriptan Succinate USP for prescription compounding, 25g CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Sumatriptan USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tacrolimus USP (Monohydrate) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tadalafil USP (Monohydrate) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone (Soy) (Micronized) USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Cypionate USP (Micronized) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone Enanthate USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Testosterone USP (Micronized) (Yam) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tramadol HCl USP (CIV) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Tretinoin USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ursodiol USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vardenafil HCl USP (trihydrate) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil HCl USP for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ascorbic Acid USP, for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Biotin USP (Vitamin H) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin (Vitamin B12) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyanocobalamin USP (Vitamin B12) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fluticasone propionate USP (Micronized) for prescription compounding CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm’s container/closure system. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Limbrel (flavocoxid 250 mg) capsules, 60-count bottle Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Limbrel (flavocoxid 500 mg) capsules, 60-count bottle Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Q.Care, Oral Cleansing & Suctioning System q4 Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products Class IIFDA’s classFeb 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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