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 Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10… Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Clocortolone Pivalate Cream, 0.1%, 90-gram tube Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Failed Impurities/Degradation Specifications Class IIIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valganciclovir Tablets, USP, 450 mg, 60-count bottle Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medicine recall Valacyclovir Tablets USP 1 gram, 30-count bottle Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named
- Medicine recall Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile Failed Stability Specification: OOS low viscosity results discovered during retain testing. Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportMissourithe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet. Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05 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 classMar 14, 2018in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereTexas
- Medicine recall Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC CGMP deviations: Ibuprofen is being recalled in response to previous recall Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug… Superpotent drug: failed assay throughout the stick after 6 months stability. Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Lynparza (olaparib) capsules 50 mg, 112 count bottles Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph). Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%)… Labeling: Label mix-up Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportArkansasthe one state its words name PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereArkansas
- Medicine recall Bella Capsules, 600mg, 30-count bottles Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 14, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 14, 2018ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall labetalol HCl injection 20 mg/4 mL Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of… Class IIIFDA’s classMar 14, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 14, 2018ClassClass IIIStatusTerminatedWhereGeorgia, Nebraska and Pennsylvania
- Medicine recall RANITIDINE Tablets, USP 150 mg UD 100 tablets Failed Stability Specifications Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acyclovir Tablets, USP, 400 mg, 50 Tablets Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9) Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus). Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC) Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used… Class IIFDA’s classMar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. Class IIIFDA’s classMar 7, 2018in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedMar 7, 2018ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall GERICARE Eyewash, sterile eye irrigating solution Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Levofloxacin Presence of Particulate Matter; contains visible particulate matter identified as mold. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 7, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 7, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Class IIIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bupivacaine HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Ropivacaine HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate and Bupivacaine HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ephedrine Sulfate Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Midazolam HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Morphine Sulfate Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fentanyl Citrate Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketamine HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Succinylcholine Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Adenosine Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Phenylephrine HCl Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Lack of sterility assurance. Class IIFDA’s classFeb 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 28, 2018ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.