Haloperidol Decanoate recalls: 12 FDA reports
Recalls involving Haloperidol Decanoate. What was wrong with each batch, and how the FDA graded the risk.
12Reports
0Class I
8Ongoing
2025-04-30Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Th
D-0368-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for BluePoint Laboratories, NDC 68001-581-41.
- Where it went
- Nationwide in the USA
- How much
- 14,189 vials
Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Th
D-0369-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-581-48.
- Where it went
- Nationwide in the USA
- How much
- 143 1x5 vials
Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeut
D-0367-2025 · Class II · reported 2025-04-30 · Ongoing
- Why it was recalled
- Lack of assurance of sterility. Bacterial contamination detected in some media fill units
- Product
- Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: BluePoint Laboratories, NDC 68001-580-41.
- Where it went
- Nationwide in the USA
- How much
- 2,110 vials
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics
D-0356-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Product
- Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
- Where it went
- U.S. Nationwide
- How much
- 4956 vials
Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeu
D-0358-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Product
- Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10
- Where it went
- U.S. Nationwide
- How much
- 240 vials
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutic
D-0355-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Product
- Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (individual carton) and NDC 70069-381-10 (10x1 mL carton)
- Where it went
- U.S. Nationwide
- How much
- 997 vials
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutic
D-0357-2025 · Class II · reported 2025-04-16 · Ongoing
- Why it was recalled
- Lack of Assurance of Sterility: Media fill with bacterial contamination
- Product
- Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and NDC 68001-581-48 (5x1 mL cartons)
- Where it went
- U.S. Nationwide
- How much
- 23,960 vials
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1m
D-0506-2024 · Class II · reported 2024-05-29 · Ongoing
- Why it was recalled
- Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Product
- Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
- Where it went
- Nationwide within the United States
- How much
- 5,578 units
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047,
D-0818-2016 · Class III · reported 2016-04-20 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
- Product
- Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
- Where it went
- Nationwide and Puerto Rico
- How much
- 48,210 units
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409
D-0421-2015 · Class II · reported 2015-04-01 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility; due to leaking vials
- Product
- Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
- Where it went
- Nationwide and Puerto Rico
- How much
- 11,030 cartons (55,150 vials)
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-
D-0422-2015 · Class II · reported 2015-04-01 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility; due to leaking vials
- Product
- Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
- Where it went
- Nationwide and Puerto Rico
- How much
- 2,523 cartons (25,936 vials)
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 N
D-0247-2015 · Class III · reported 2014-11-19 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
- Product
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01
- Where it went
- Nationwide and Puerto Rico
- How much
- 216,517 vials
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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