PillHaloperidol Decanoate
Brands: Haldol Decanoate · Haloperidol Decanoate
15 active makers
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US acquisition costNADAC · per unit
Average across 43 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it15 active · 1 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Somerset Therapeutics, LLC | unknown | 15 | SUPPLYING |
| Lifestar Pharma LLC | unknown | 11 | SUPPLYING |
| BluePoint Laboratories | unknown | 11 | SUPPLYING |
| Zydus Pharmaceuticals USA Inc. | unknown | 8 | SUPPLYING |
| Zydus Lifesciences Limited | unknown | 8 | SUPPLYING |
| Fresenius Kabi USA, LLC | unknown | 5 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 4 | SUPPLYING |
| Gland Pharma Limited | unknown | 4 | SUPPLYING |
| Caplin Steriles Limited | unknown | 3 | SUPPLYING |
| Meitheal Pharmaceuticals Inc. | unknown | 3 | SUPPLYING |
| Armas Pharmaceuticals Inc. | unknown | 3 | SUPPLYING |
| Patriot Pharmaceuticals | unknown | 2 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 2 | SUPPLYING |
| Mylan Institutional LLC | unknown | 2 | SUPPLYING |
| NorthStar RxLLC | unknown | 1 | SUPPLYING |
+ 1 more labelers
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jan 9, 2026RESOLVEDShortage resolved: Haloperidol Decanoate Injection (Fresenius Kabi USA, LLC)
Haloperidol Decanoate Injection — reported in shortage by Fresenius Kabi USA, LLC. Therapeutic category: Psychiatry.
- Jan 9, 2026SHORTAGEDrug shortage: Haloperidol Decanoate Injection (Fresenius Kabi USA, LLC)
Haloperidol Decanoate Injection — reported in shortage by Fresenius Kabi USA, LLC. Therapeutic category: Psychiatry.
- Apr 2, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limit…
Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Recalling firm: Amerisource Health Services LLC — Nationwide in the USA
- Apr 2, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutic…
Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Recalling firm: Amerisource Health Services LLC — Nationwide in the USA
- Apr 2, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutic…
Lack of assurance of sterility. Bacterial contamination detected in some media fill units — Recalling firm: Amerisource Health Services LLC — Nationwide in the USA
- Mar 21, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited…
Lack of Assurance of Sterility: Media fill with bacterial contamination — Recalling firm: Somerset Therapeutics Private Limited — U.S. Nationwide
- Mar 21, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, S…
Lack of Assurance of Sterility: Media fill with bacterial contamination — Recalling firm: Somerset Therapeutics Private Limited — U.S. Nationwide
- Mar 21, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC…
Lack of Assurance of Sterility: Media fill with bacterial contamination — Recalling firm: Somerset Therapeutics Private Limited — U.S. Nationwide
- Mar 21, 2025RECALLRecall (Class II): Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,…
Lack of Assurance of Sterility: Media fill with bacterial contamination — Recalling firm: Somerset Therapeutics Private Limited — U.S. Nationwide
- Apr 24, 2024RECALLRecall (Class II): Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-…
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI). — Recalling firm: SOMERSET THERAPEUTICS LLC — Nationwide within the United States
- Apr 7, 2016RECALLRecall (Class III): Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323…
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. — Recalling firm: Fresenius Kabi USA, LLC — Nationwide and Puerto Rico
- Feb 18, 2015RECALLRecall (Class II): Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packa…
Lack of Assurance of Sterility; due to leaking vials — Recalling firm: Mylan Institutional LLC — Nationwide and Puerto Rico
- Feb 18, 2015RECALLRecall (Class II): Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) pack…
Lack of Assurance of Sterility; due to leaking vials — Recalling firm: Mylan Institutional LLC — Nationwide and Puerto Rico
- Apr 14, 2014RECALLRecall (Class III): HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323…
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result. — Recalling firm: Fresenius Kabi USA LLC — Nationwide and Puerto Rico