CLASS I Drug recall · Reported 10 Jul 2019 · FDA Enforcement Report

Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL recalled

PharMEDium Services is recalling Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL in BD Syringe, PharMEDium 913 N, distributed nationwide in the US. The recall was initiated on 7 Jun 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.

Quantity recalled28,140 syringes

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-1488-2019
FDA event ID: 83207
Recalling firm: PharMEDium Services, Dayton, NJ
Classification: Class I
Status: Terminated
Recall initiated: 7 Jun 2019
FDA classified: 16 Jul 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Undeclared Sulfites
Drug class: Pain Medication

Timeline

7 Jun 2019	Recall initiated by company
10 Jul 2019	Published in enforcement report	+33 days
16 Jul 2019	Classified by FDA	+6 days

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

Reason for recall

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 as listed by the FDA

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 was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it 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

Which lots are affected?

Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.

Where was it sold?

Nationwide within the United States

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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.

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Other Hydromorphone recalls

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Reported	Class	Recall	Company	Reason	Where
30 Apr 2025Drug	CLASS III	HYDROmorphone Hydrochloride 50mg/ (1mg/mL) recalled by OurPharma	OurPharma	Potency & Assay	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 25 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 20 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide