Haloperidol Decanoate: 11 recalls on record

Recalled by 1 agency: FDA (11).

First recall on record: November 19, 2014. Most recent: April 30, 2025.

Risk classification: Class II: 10 · Class III: 1

Most recent recalls

DateAgencyProduct
April 30, 2025FDAHaloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured …D-0367-2025
April 30, 2025FDAHaloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufac…D-0368-2025
April 30, 2025FDAHaloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufac…D-0369-2025
April 16, 2025FDAHaloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured f…D-0358-2025
April 16, 2025FDAHaloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by:…D-0357-2025
April 16, 2025FDAHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for:…D-0355-2025
April 16, 2025FDAHaloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: …D-0356-2025
May 29, 2024FDAHaloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069…D-0506-2024
April 1, 2015FDAHaloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose …D-0422-2015
April 1, 2015FDAHaloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose…D-0421-2015
November 19, 2014FDAHALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, S…D-0247-2015

Questions about this brand

How many recalls does Haloperidol Decanoate have?
Recalert has 11 U.S. recalls on record for Haloperidol Decanoate, published between November 19, 2014 and April 30, 2025.
What was the most recent Haloperidol Decanoate recall?
FDA recall D-0367-2025, published April 30, 2025: 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, …
Which agencies have recalled Haloperidol Decanoate products?
Haloperidol Decanoate products appear in recalls from: FDA (11).

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