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 20 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 20 mcg/mL HYDROmorphone HCl and 0.06% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 20 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 20 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3 mcg/mL Fentanyl Citrate and 0.01% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 4 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 4 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 4 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.04% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.05% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL Fentanyl Citrate and 0.25% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL HYDROmorphone HCl and 0.075% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 6.66 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 8 mcg/mL HYDROmorphone HCl and 0.05% Bupivacaine HCl (Preservative Free) Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs. Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube Penicillin Cross Contamination Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube Penicillin Cross Contamination Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes Penicillin Cross Contamination Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube Penicillin Cross Contamination Class IIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Failed Dissolution Specifications Class IIIFDA’s classJul 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 27, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG, B5-12.5MG, B6-12.5MG/ML, 2ML… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 2ML Vials… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG/ML, In a) 5ML… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML, 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-50MG/ML,… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG, CYANO B12… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-2MG, B6-2MG,… Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EDTA DISODIUM 15% Lack of Assurance of Sterility Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 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.”
Your shortlist0 of 4
Add one more to compare.