thejoe Key Pharmacy and Compounding Center

Key Pharmacy and Compounding Center: 79 FDA recall reports

Every drug recall the FDA has published for Key Pharmacy and Compounding Center. The fault, and how the agency graded it.

79Reports

0Class I

0Ongoing

2017-05-24Most 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	79

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.

PROCAINE HCL 5ML SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by K

D-0772-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PROCAINE HCL *5ML* SDV SULFITE FREE 1% INJ, Injection, 1%, RXxonly, 5mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 40 vials

QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Gl

D-0755-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 1 vial

ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared

D-0758-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: ALPHA LIPOIC ACID 25ML MDV 25MG/ML INJ, Injection, 25mg/mL, Rx only, 25 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 1 vial

SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key

D-0779-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: SODIUM CARBOXYM-CELL PF 0.5% OPHTH, opthalmic, 0.50%, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 30 mL

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dos

D-0786-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 5/2 mL vials

PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Pre

D-0756-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PGE1/PROCAINE 5ML MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 3 vials

VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Do

D-0785-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 6/1mL vials

PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared b

D-0773-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 86 vials total (78/5mL vials and 8/50mL vials)

HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepar

D-0728-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: HYDROXO-B12 5ML PBF MDV (CALIF) 10MG/ML INJ, Injection, 10mg/mL, RX only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 1 vial

TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/M

D-0751-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TRI MIX 5.95/17.8572/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 5.95mcg/17.85mg/0.6mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 4 vials

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key

D-0708-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: 5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 6 vials

PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepare

D-0730-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PAPAVERINE/PHENT 5ML MDV 30/1MG/ML INJ, Injection, 30mg/1mg/mL, Rx only, 5mL glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 4 vials

5-MTHF 10ML MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compo

D-0707-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: 5-MTHF *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 100 vials

TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prep

D-0782-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TESTOST CYP SESAME OIL 5ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 2 vials

HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key C

D-0722-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: HYDROXO-B12 1ML SDV 10MG/ML INJ, Injection, 10mg/mL, Rx only, 1 mL glass/ Single Dose vial, Prepared by Key Compounding Pharmacy HYDROXO-B12 2ML SDV 10MG/ML INJ, Injection, 10mg/mL, RX only, 2 mL glass/ Single Dose vial.
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 50 vials total (10/1mL vials and 40/2mL vials)

TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Do

D-0741-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TRI MIX 16.7/4/0.27 5ML MDV MCG/MG/MG/ML INJ, Injection, 16.7mcg/4mg/0.27mg/ml, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 1 vial

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose v

D-0710-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: 5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)

TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glas

D-0750-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TRI MIX 5.88/17.65/0.588 5ML MDV MCG/MG/MG/ML INJ, , Injection, 5.88mcg/17.65mg/0.588mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 3 vials

TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial

D-0746-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 2 vials

HCG 10ML MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compo

D-0720-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 72 vials

PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Pr

D-0757-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 4 vials

SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Singl

D-0781-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 91 vials

METHYL-B12 10ML MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key

D-0770-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: METHYL-B12 *10ML* MDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 25 vials

PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared

D-0776-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PYRIDOXAL-5-PHOS 10ML MDV 100MG/ML INJ, Injection, 100mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 1 vial

TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, P

D-0783-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 6 vials total (5/5mL vials and 1/10mL vial)

PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepare

D-0734-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 2 vials

QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/M

D-0754-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: QUAD MIX 1/30/0.5/0.1 5ML MDV MCG/MG/MG/MG/ML INJ, Injection, 1mcg/30mg/0.5mg/0.15mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 2 vials

TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial

D-0742-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: TRI MIX 20/20/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 25 vials

HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepa

D-0723-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 240 mL

5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key C

D-0709-2017 · Class II · reported 2017-05-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Product: 5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy
Where it went: Distributed nationwide in U.S.A., Australia and Canada.
How much: 3 vials

Showing the 30 most recent of 79. 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.

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