CLASS II Drug recall · Reported 15 Apr 2020 · FDA Enforcement Report

fentaNYL Citrate Injection, 50 mcg per mL recalled

PharMEDium Services is recalling fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per syringe, For IV Use, distributed nationwide in the US. The recall was initiated on 16 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes193530007D, Exp 3/19/2020

Quantity recalled75 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1092-2020
FDA event ID: 85212
Recalling firm: PharMEDium Services, Dayton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2020
FDA classified: 6 Apr 2020
Reported: 15 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Pain Medication

Timeline

16 Mar 2020	Recall initiated by company
6 Apr 2020	Classified by FDA	+21 days
15 Apr 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 was distributed

Distributed Nationwide in the US

Nationwide

Questions about this recall

Why was it recalled?

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

Which lots are affected?

193530007D, Exp 3/19/2020

Where was it sold?

Distributed Nationwide in the US

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 85212

This product is part of a recall event; the main page for the event is succinylcholine Chloride, 20 mg per, 100 mg per BD Syringe recalled.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020	CLASS II	succinylcholine Chloride, 20 mg per, 100 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	ePHEDrine Sulfate 5 mg per mL 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	ePHEDrine Sulfate 10 mg per mL 50 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	fentaNYL Citrate 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	fentaNYL Citrate Injection 50 mcg per mL recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 50 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020	CLASS II	rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide

More recalls from PharMEDium Services

All 291

Reported	Class	Recall	Company	Reason	Where
15 Apr 2020Drug	CLASS II	rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	fentaNYL Citrate 10 mcg per mL, 2,500 mcg per in a LifeCare recalled	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	nICARdipine HCl (0.1 mg/mL) 1 mg recalled by PharMEDium Services	PharMEDium Services	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled	PharMEDium Services	Sterility	Nationwide

Other Fentanyl recalls

All 248

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS II	fentaNYL Citrate, 1,000 mcg recalled by OurPharma	OurPharma	Other	Nationwide
27 May 2026Drug	CLASS II	fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled	IntegraDose Compounding Services	Potency & Assay	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, CII recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
6 May 2026Drug	CLASS II	fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide