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 Phenylephrine HCI (PF) 100mcg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Morphine Sulfate 5mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ketamine 2 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ephedrine Sulfate 5 mg/ml Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ropivacaine HCI 0.2% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Lidocaine 2%, 5 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Rocuronium 10 mg/mL, 5 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Cefazolin 1GM in Sterile Water, 10 ml BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Ephedrine Sulfate 5 mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Fentanyl Citrate 50 mcg/mL, 5ml syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Midazolam HCI 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Vecuronium 1mg/mL in Sterile Water ,10 mL BD syringe Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Midazolam HCl 1mg/mL Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Bupivacaine HCI 0.25% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Maryland, North Carolina, Oklahoma, Texas and Virginia named
- Medicine recall PATCH-REMOUING PILL (For Facial Pigmentation) Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall ChingChunBao ANTI-AGING TABLETS Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FUCONPO CAPSULE Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall SCIATICA PILLS Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall CROCODILE BILE PILL FOR ASTHMA Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tien Ma Tou Tong Wan (Condensed pills) Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall LARYNGITIS PILLS Herbal Supplement Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated) Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall GASTRODIA CAPSULES Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall WUPOOSER KAI YEUNG PILL Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FARSER KAI YEUNG PILL Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PING ON OINTMENT RELIEF FOR MUSCULAR PAIN Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall FUQINGSONG RELIEF CREAM (Flucinonide Ointment) Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diazepam Injection USP 10mg/2mL Crystallization: Product contains particulate identified to be crystallized active ingredient. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles Failed Dissolution Specification: Out of specification dissolution results when testing product stability. Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Hawaii and Puerto Rico named
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles Failed Dissolution Specification: Out of specification dissolution results when testing product stability. Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Hawaii and Puerto Rico named
- Medicine recall Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles Failed Dissolution Specification: Out of specification dissolution results when testing product stability. Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Hawaii and Puerto Rico named
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles Failed Impurities/Degradation Specification; 9 month stability Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL Subpotency: product assayed and found OOS for cyproheptadine Class IIIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNew Jerseythe one state its words name PublishedJul 13, 2016ClassClass IIIStatusTerminatedWhereNew Jersey
- Medicine recall Sirolimus Tablets, 1 mg, 100-count bottle Failed impurities/degradation: out of specification result for impurity secorapamycin. Class IIIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Tazorac (tazarotene) Gel 0.05% Failed Content Uniformity Specifications. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612 Failed Content Uniformity Specifications. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall PHENYLephrine 1 mg/10 mL Labeling: Label Error on Declared Strength. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 13, 2016ClassClass IStatusTerminatedWhereCalifornia
- Medicine recall All 4-aminopyridine Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall CAP-BIOTIN 100 MG Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All testosterone Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
- Medicine recall All estriol Products Lack of Processing Controls Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Hawaii and New Mexico
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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