SterRx, LLC

SterRx, LLC: 35 FDA recall reports

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

35Reports
1Class I
0Ongoing
2023-07-26Most recent
1 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 II34
Class I1

By year reported

YearReports
20212
202228
20235
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.

Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 25

D-0931-2023  ·  Class II  ·  reported 2023-07-26  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01.
Where it went
Nationwide in the USA
How much
132,299 bags

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag,

D-0930-2023  ·  Class II  ·  reported 2023-07-26  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Where it went
Nationwide in the USA
How much
137,304 bags

Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 2

D-0933-2023  ·  Class II  ·  reported 2023-07-26  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01.
Where it went
Nationwide in the USA
How much
92,148 bags

Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 25

D-0932-2023  ·  Class II  ·  reported 2023-07-26  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01.
Where it went
Nationwide in the USA
How much
125,598 bags

Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in

D-0934-2023  ·  Class II  ·  reported 2023-07-26  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01.
Where it went
Nationwide in the USA
How much
2,088 bags

fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Ida

D-1332-2022  ·  Class II  ·  reported 2022-08-17  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
Where it went
Nationwide within the United States
How much
360 bags

FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho A

D-1331-2022  ·  Class II  ·  reported 2022-08-17  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Where it went
Nationwide within the United States
How much
720 bags

MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idah

D-0318-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-427-01.
Where it went
U.S.A. Nationwide
How much
880 bags

NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., P

D-0319-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Where it went
U.S.A. Nationwide
How much
1044 bags

NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave.,

D-0322-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
Where it went
U.S.A. Nationwide
How much
36,576 bags

NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho

D-0321-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-676-01.
Where it went
U.S.A. Nationwide
How much
74,508 bags

Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Id

D-0316-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-01.
Where it went
U.S.A. Nationwide
How much
10660 bags

PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141

D-0323-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
Where it went
U.S.A. Nationwide
How much
20640 bags

Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Ave

D-0307-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
Where it went
U.S.A. Nationwide
How much
3540 bags

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho

D-0306-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Where it went
U.S.A. Nationwide
How much
127,260 bags

Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Pl

D-0300-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #70324-102-01.
Where it went
U.S.A. Nationwide
How much
15660 bags

Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., P

D-0313-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-452-01.
Where it went
U.S.A. Nationwide
How much
40 bags

dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Av

D-0302-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Where it went
U.S.A. Nationwide
How much
24300 bags

Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave.,

D-0312-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-102-02.
Where it went
U.S.A. Nationwide
How much
36360 bags

NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho

D-0320-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-651-01.
Where it went
U.S.A. Nationwide
How much
121,584 bags

Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324

D-0325-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Where it went
U.S.A. Nationwide
How much
2886 bags

PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenu

D-0305-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
Where it went
U.S.A. Nationwide
How much
18,948 bags

NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plat

D-0303-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-451-01.
Where it went
U.S.A. Nationwide
How much
9360 bags

Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141

D-0317-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
Where it went
U.S.A. Nationwide
How much
5000 bags

EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho A

D-0310-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
Where it went
U.S.A. Nationwide
How much
5832 bags

EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Av

D-0311-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
Where it went
U.S.A. Nationwide
How much
684 bags

EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave.

D-0304-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
Where it went
U.S.A. Nationwide
How much
2779 bags

dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., P

D-0315-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-951-01.
Where it went
U.S.A. Nationwide
How much
8946 bags

EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Av

D-0308-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
Where it went
U.S.A. Nationwide
How much
26,928 bags

PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 I

D-0324-2022  ·  Class II  ·  reported 2022-01-05  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility
Product
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
Where it went
U.S.A. Nationwide
How much
23,136 bags

Showing the 30 most recent of 35. 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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