Pharmedium Services, LLC

Pharmedium Services, LLC: 291 FDA recall reports

Every drug recall the FDA has published for Pharmedium Services, LLC. The fault, and how the agency graded it.

291Reports
19Class I
0Ongoing
2020-04-15Most recent
19 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

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.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt 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

ClassReports
Class II248
Class III24
Class I19

By year reported

YearReports
201515
2016151
201750
201857
20192
202016
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.

succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davi

D-1086-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
Where it went
Distributed Nationwide in the US
How much
2475 units

ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, P

D-1090-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL BD Syringe, For IV Use, Rx Only, PharMEDium 913 N. Davis Ave. Cleveland, MS 98732 NDC 71030-003-02
Where it went
Distributed Nationwide in the US
How much
1500 units

ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx On

D-1091-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride 5 mL syringe, For IV Use, Rx Only, PharMEDium 913 N Davis Avenue Cleveland, MS NDC 71030-001-09
Where it went
Distributed Nationwide in the US
How much
900 units

fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Vo

D-1089-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Where it went
Distributed Nationwide in the US
How much
290 units

fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Ser

D-1092-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, For IV Use, Rx Only, PharMEDium Services, LLC 36 Stutte Road Dayton, NJ. NDC 61553-306-33
Where it went
Distributed Nationwide in the US
How much
75 units

HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject

D-1084-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
Where it went
Distributed Nationwide in the US
How much
1840 units

fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium

D-1093-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe, For IV Use, Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 05810. NDC 61553-303-28
Where it went
Distributed Nationwide in the US
How much
1350 units

ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservati

D-1081-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 mL syringe, For IV Use Preservative Free PharMEDium 913 N. Davis Ave. Cleveland, MS NDC 71030-003-12
Where it went
Distributed Nationwide in the US
How much
1075 units

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cle

D-1083-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC 71019-321-10
Where it went
Distributed Nationwide in the US
How much
4625 units

nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Onl

D-1082-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP, 10 ml in a 20mL syringe, Rx Only, PharMEDium Services LLC 12620 W. Airport Boulevard #130 Sugar Land, TX 77470. NDC 71019-206-01
Where it went
Distributed Nationwide in the US
How much
80 units

fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx O

D-1085-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
Where it went
Distributed Nationwide in the US
How much
210 units

ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservativ

D-1088-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL syringe, For IV use, Preservative Free, PharMEDium 913 W Davis Ave Cleveland MS 38732 NDC 71030-003-09
Where it went
Distributed Nationwide in the US
How much
375 units

rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Clev

D-1087-2020  ·  Class II  ·  reported 2020-04-15  ·  Terminated

Why it was recalled
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Product
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use, PharMEDium 13N. Davis Ave. Cleveland MS 36732. NDC 71019-321-05
Where it went
Distributed Nationwide in the US
How much
2250 units

NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 m

D-0626-2020  ·  Class III  ·  reported 2020-01-01  ·  Terminated

Why it was recalled
Subpotent Drug
Product
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Where it went
Nationwide in the U.S.
How much
864 bags

NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 m

D-0625-2020  ·  Class III  ·  reported 2020-01-01  ·  Terminated

Why it was recalled
Subpotent Drug
Product
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Where it went
Nationwide in the U.S.
How much
5820 bags

NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 m

D-0627-2020  ·  Class III  ·  reported 2020-01-01  ·  Terminated

Why it was recalled
Subpotent Drug
Product
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
Where it went
Nationwide in the U.S.
How much
5808 bags
Class I

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave C

D-1488-2019  ·  Class I  ·  reported 2019-07-10  ·  Terminated

Why it was recalled
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Product
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Where it went
Nationwide within the United States
How much
28,140 syringes

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton,

D-0374-2019  ·  Class II  ·  reported 2019-01-16  ·  Terminated

Why it was recalled
Subpotent
Product
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.
Where it went
Product was distributed throughout the United States.
How much
7,711 syringes

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection

D-0334-2019  ·  Class II  ·  reported 2018-12-26  ·  Terminated

Why it was recalled
Sub-potent
Product
Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48
Where it went
Nationwide in the USA.
How much
295 100 mL in 150 mL Intravia bags

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection,

D-0333-2019  ·  Class II  ·  reported 2018-12-26  ·  Terminated

Why it was recalled
Sub-potent
Product
Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75.
Where it went
Nationwide in the USA.
How much
295 50 ml in 60 ml syringes

10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.

D-1045-2018  ·  Class II  ·  reported 2018-08-15  ·  Terminated

Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product
10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
Where it went
Product was distributed throughout the United States
How much
575 Syringes

5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged

D-1044-2018  ·  Class II  ·  reported 2018-08-15  ·  Terminated

Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product
5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
Where it went
Product was distributed throughout the United States
How much
450 Syringes

10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mc

D-1043-2018  ·  Class II  ·  reported 2018-08-15  ·  Terminated

Why it was recalled
CGMP deviations: Product was released while a hood certification discrepancy was being investigated.
Product
10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
Where it went
Product was distributed throughout the United States
How much
230 Intravia Bags

HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Ser

D-0854-2018  ·  Class II  ·  reported 2018-06-20  ·  Terminated

Why it was recalled
Superpotent and Subpotent
Product
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Where it went
Nationwide
How much
2,800 syringes

Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDiu

D-0632-2018  ·  Class III  ·  reported 2018-04-25  ·  Terminated

Why it was recalled
cGMP deviations
Product
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
Where it went
MA, WA
How much
72 bags

Glycopyrrolate in all strengths, all doses, and all packaging.

D-0454-2018  ·  Class II  ·  reported 2018-02-28  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Glycopyrrolate in all strengths, all doses, and all packaging.
Where it went
U.S.A. Nationwide
How much
Unknown

HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.

D-0428-2018  ·  Class II  ·  reported 2018-02-28  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.
Where it went
U.S.A. Nationwide
How much
Unknown

Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.

D-0437-2018  ·  Class II  ·  reported 2018-02-28  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging.
Where it went
U.S.A. Nationwide
How much
Unknown

Fentanyl Citrate Injection in all strengths, all doses, and all packaging.

D-0450-2018  ·  Class II  ·  reported 2018-02-28  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
Where it went
U.S.A. Nationwide
How much
Unknown

Labetalol HCl in all strengths, all doses, and all packaging.

D-0447-2018  ·  Class II  ·  reported 2018-02-28  ·  Terminated

Why it was recalled
Lack of sterility assurance.
Product
Labetalol HCl in all strengths, all doses, and all packaging.
Where it went
U.S.A. Nationwide
How much
Unknown

Showing the 30 most recent of 291. 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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