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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96636

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 02, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Amerisource Health Services LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

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.

D-0367-2025
Recall number
D-0367-2025
Initiated
April 02, 2025
Classification
Class II
Status
Ongoing
Quantity
2,110 vials

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Bacterial contamination
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Code information

A240467B, EXP 07/31/2026

Distribution pattern

Nationwide in the USA

drug · product 2 of 3

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.

D-0368-2025
Recall number
D-0368-2025
Initiated
April 02, 2025
Classification
Class II
Status
Ongoing
Quantity
14,189 vials

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Bacterial contamination
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Code information

A240482A, EXP 08/31/2026

Distribution pattern

Nationwide in the USA

drug · product 3 of 3

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.

D-0369-2025
Recall number
D-0369-2025
Initiated
April 02, 2025
Classification
Class II
Status
Ongoing
Quantity
143 1x5 vials

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Bacterial contamination
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility. Bacterial contamination detected in some media fill units

Code information

A240482B, EXP 08/31/2026

Distribution pattern

Nationwide in the USA