Opioid Agonist
Where is Hydromorphone made?
16 companies sell it under their own name and 10 repackagers rebottle it. Their labels name 10 factories in the United States.
United States 10
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC Dilaudid, Hydromorphone Hydrochloride0.2 mg per 1 mL, 1 mg per 1 mL, 2 mg per 1 mL, 4 mg per 1 mL, 10 mg per 1 mL · NDC 76045-121, 63323-852, 76045-009 +4 | Fresenius Kabi USA, LLCMakes it and tests it | Grand Island, NY, United States | Problems found, fixed voluntarilyOct 2023 |
| Fresenius Kabi USA, LLCMakes it and tests it | Wilson, NC, United States | Problems found, fixed voluntarilyFeb 2026 | |
| Hospira, Inc. Hydromorphone Hydrochloride0.25 mg per 0.5 mL, 0.5 mg per 0.5 mL, 1 mg per 1 mL, 2 mg per 1 mL, 4 mg per 1 mL, 10 mg per 1 mL · NDC 0409-1805, 0409-4264, 0409-2552 +7 | Hospira, Inc.Makes it, tests it, packages it and labels it | Rocky Mount, NC, United States | No problems foundFeb 2025 |
| Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 | |
| Akorn10 mg per 1 mL · NDC 17478-540 | AkornMakes it, tests it and sterilizes it | Location not on file | Not inspected on record |
| Ascent Pharmaceuticals, Inc.2 mg, 4 mg, 5 mg per 5 mL, 8 mg, 12 mg, 16 mg · NDC 43602-267, 43602-268, 43602-002 +5 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Aurolife Pharma LLC2 mg, 4 mg, 8 mg · NDC 13107-107, 13107-108, 13107-109 | Aurolife Pharma LLCMakes it | Dayton, NJ, United States | Serious problems, FDA actionDec 2021 |
| Camber Pharmaceuticals Inc.8 mg, 12 mg, 16 mg, 32 mg · NDC 31722-120, 31722-121, 31722-122 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Hikma Pharmaceuticals USA Inc. Hydromorphone Hydrochloride0.2 mg per 1 mL, 0.5 mg per 0.5 mL, 1 mg per 1 mL, 2 mg per 1 mL · NDC 0641-6259, 0641-6206, 0641-6169 +5 | Hikma Pharmaceuticals USA Inc.Makes it, tests it, packages it and labels it | Cherry Hill, NJ, United States | No problems foundMay 2026 |
| Hikma Pharmaceuticals USA Inc.1 mg per 1 mL, 4 mg, 8 mg · NDC 0054-0386, 0054-0264, 0054-0265 | West-Ward Columbus Inc.Makes it | Columbus, OH, United States | No problems foundApr 2026 |
| Rhodes Pharmaceuticals L.P. Dilaudid2 mg, 4 mg, 5 mg per 5 mL, 8 mg · NDC 42858-301, 42858-122, 42858-302 +5 | Knoa Pharmaceuticals LLCMakes it | Wilson, NC, United States | Problems found, fixed voluntarilySep 2025 |
| SpecGx LLC2 mg, 4 mg, 8 mg · NDC 0406-3243, 0406-3244, 0406-3249 | SpecGx LLCMakes it and tests it | Hobart, NY, United States | No problems foundMar 2020 |
| Teva Parenteral Medicines, Inc.10 mg per 1 mL · NDC 0703-0110, 0703-0113, 0703-0018 | Hospira, Inc.Makes it, tests it, packages it and labels it | McPherson, KS, United States | Problems found, fixed voluntarilyJan 2025 |
| XLCare Pharmaceuticals, Inc.8 mg, 12 mg, 16 mg, 32 mg · NDC 72865-169, 72865-170, 72865-171 +1 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Cantrell Drug Company0.1 mg per 1 mL, 0.4 mg per 1 mL, 0.5 mg per 1 mL, 2 mg per 1 mL, 10 mg per 1 mL · NDC 52533-004, 52533-145, 52533-005 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC3 mg, 8 mg, 12 mg, 16 mg, 32 mg · NDC 0574-0294, 0574-0295, 0574-7224 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Trigen Laboratories, LLC8 mg, 12 mg, 16 mg, 24 mg, 32 mg · NDC 13811-702, 13811-703, 13811-720 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| V1 Pharma Llc8 mg · NDC 70399-102 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydromorphone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- American Health Packaging:
60687-579,60687-590,60687-566 - Asclemed USA, Inc.:
87063-037,87063-038,87063-039 - Atlantic Biologicals Corps.:
17856-0386 - Bryant Ranch Prepack:
63629-4284,63629-2532,71335-0723,71335-9701 - H.J. Harkins Co., Inc.:
52959-420,52959-408,52959-413 - Lohxa:
70166-250 - Physicians Total Care, Inc.:
54868-6388,54868-3165,54868-4969,54868-4598+1 - RedPharm Drug. Inc.:
67296-1642,67296-1414 - St. Mary's Medical Park Pharmacy:
60760-998 - Stat Rx USA:
16590-827,42549-594,42549-574,16590-774+1
Recalls
- Feb 7, 2018 · Class I · Pfizer Inc. · 2 recall notices
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked. - Aug 22, 2017 · Class II · Pfizer Inc.
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process. - Jul 26, 2017 · Class II · Hospira Inc, Lake Forest · 3 recall notices
Presence of Particulate Matter: Silicone oil - Oct 1, 2014 · Class II · Hospira Inc.
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked. - Aug 15, 2012 · Class I · Hospira Inc.
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. - May 12, 2012 · Class I · Hospira Inc.
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.