Medicines, 2016
Shortlist up to four to read them side by side.
1,254 medicine recalls FDA’s Enforcement Report published in 2016, 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 5, 2026.
1,254of 1,254 medicine recallsshown with your filters
The list
- Medicine recall lidocaine HCl, 2%, 20 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall methadone HCl, 1 mg per mL Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall methadone HCl, 2.5 mg per 0.5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall midazolam HCl, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall midazolam HCl, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall midazolam HCl, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 0.5 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 0.5 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 1 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall morphine Sulfate, 2 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV… Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 1% Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall lidocaine HCl, 2%, 20 mg per mL Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall fentaNYL Citrate, 10 mcg per 1 mL Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection USP, 100mL in a 150 mL PAB container Non-Sterility: fungal contamination due to leaking containers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IStatusTerminatedWhereNationwide
- Medicine recall mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. Class IIIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack Failed Dissolution Specifications Class IIIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall TAZORAC (tazarotene) Gel 0.05% Failed Content Uniformity Specifications Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall TAZORAC (tazarotene) Gel 0.05% Failed Content Uniformity Specifications Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin 5000 mcg/mL Injection Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Phenotolamine 0.4mg/Prostaglandin 20mcg/mL Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) Lack of Assurance of Sterility; medication was sterilized with a recalled filter Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportOklahomathe one state its words name PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereOklahoma
- Medicine recall Claravis (isotretinoin capsules USP), 10mg Failed Impurities/Degradation Specifications. Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle Presence of Foreign Tablets/Capsules Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day Failed Dissolution Specifications Class IIIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PredniSONE Tablets USP, 1 mg, 100-count bottles Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. Class IIFDA’s classOct 12, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 12, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. Class IIIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Sennazon (sennosides) Syrup, 8.8 mg, 8 fl CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5… CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Senna Syrup (sennosides) 8.8 mg, 8 fl CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. Class IIFDA’s classOct 5, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 5, 2016ClassClass 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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