thejoe Assurance Infusion

Assurance Infusion: 118 FDA recall reports

Every drug recall the FDA has published for Assurance Infusion. The fault, and how the agency graded it.

118Reports

0Class I

0Ongoing

2020-01-22Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	118

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-880

D-0749-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 2 syringes/1 vial

BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0666-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0680-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0743-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 4 syringes

HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0739-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0670-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0711-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0691-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0713-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0704-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0682-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

D-0736-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
Where it went: Nationwide within the United States
How much: 2 vials

BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0695-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0729-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

D-0770-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 5 vials

MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0754-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0719-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0766-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 134 vials

HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0738-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-88

D-0675-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0676-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 2 syringes

BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0671-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0777-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 10 vials

HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0741-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800

D-0748-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 5 vials

BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0694-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

D-0775-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 10 vials

BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8

D-0668-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0699-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 1 syringe

MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

D-0759-2020 · Class II · reported 2020-01-22 · Terminated

Why it was recalled: Lack of sterility assurance.
Product: MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Where it went: Nationwide within the United States
How much: 2 syringes

Showing the 30 most recent of 118. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

← All drug recalls