Hydromorphone recalls

The FDA has published 155 recalls involving Hydromorphone since 2012. The latest was reported on 30 Apr 2025. Most were for sterility. The Compounding Pharmacy of America has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls155since 2012

Last 12 months0reported

Class I53% of total

Ongoing2latest 30 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 3%Class II 148 95%Class III 2 1%

Why hydromorphone is recalled

Companies

The Compounding Pharmacy of America3321%
Pharmedium Services2315%
SCA Pharmaceuticals138%
Hartley Medical Center Pharmacy138%
Central Admixture Pharmacy Services128%
Assurance Infusion85%
Coast Quality Pharmacy75%
Nephron Sterile Compounding Center64%

By year

202511%
202475%
2023149%
2022106%
202132%
2020106%
2019117%
2018128%
201785%
20163825%

Ongoing hydromorphone recalls

2 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Hydromorphone Hydrochloride Injection, USP, 50mg/ (10 mg/mL) recalled	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge syringe (0.2 mg/mL) recalled	SSM Health Care St. Louis	Manufacturing (CGMP) Deviations	MO

All hydromorphone recalls, newest first

155 total

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
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 6 mg/ in 0.9% Sodium Chloride recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 10 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
3 Apr 2024Drug	CLASS II	HYDROmorphone HCl 30 mg/ in 0.9% Sodium Chloride Injection recalled	SCA Pharmaceuticals	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in dextrose 5%, 3 mg/, (0.1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in 0.9% Sodium Chloride, 30 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in dextrose 5%, 0.5 mg/, (0.1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 10 mg/, (0.2 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 15 mg/, (0.5 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
11 Oct 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 6 mg/, (0.2 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 6 mg/, (0.2 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in Dextrose 5%, 0.5 mg/ (0.1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 30 mg/, (1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 10 mg/, (0.2 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in dextrose 5%, 3 mg/, (0.1 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
9 Aug 2023Drug	CLASS II	HYDROmorphone in 0.9% sodium chloride, 15 mg/, (0.5 mg/mL) Syringe recalled	Central Admixture Pharmacy Services	Sterility	Nationwide
7 Jun 2023Drug	CLASS II	Hydromorphone Hydrochloride Injection, USP, 50mg/ (10 mg/mL) recalled	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge syringe (0.2 mg/mL) recalled	SSM Health Care St. Louis	Manufacturing (CGMP) Deviations	MO
27 Jul 2022Drug	CLASS II	HYDROmorphone HCl Injection, USP, 10 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	HYDROmorphone HCl Injection, USP, 50 mg/ (1 mg/mL) syringes recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	HYDROmorphone HCl Injection, USP 30 mg/ (1 mg/mL) syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
27 Jul 2022Drug	CLASS II	HYDROmorphone HCl Injection, USP, 6 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022Drug	CLASS II	Hydromorphone HCl Injection, USP, 50 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Jun 2022Drug	CLASS II	Hydromorphone HCl Injection, USP, 6 mg recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
23 Mar 2022Drug	CLASS II	Hydromorphone HCl 1 mg/mL recalled by Family Pharmacy of Statesville	Family Pharmacy of Statesville	Sterility	NC
23 Mar 2022Drug	CLASS II	Hydromorphone HCl 5 mg/mL Infusion recalled	Family Pharmacy of Statesville	Sterility	NC

Should you stop taking Hydromorphone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.