Exact FDA event identifier

Event 96569

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

Event summary

Timeline bucket: March 21, 2025
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Somerset Therapeutics Private Limited

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

5 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 5

Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)

D-0354-2025

Recall number: D-0354-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Quantity: 506,080 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: Media fill with bacterial contamination

Code information

NDC 70069-101-25; A240304, A240305, A240320, A240322, A240334, A240335, A240340, exp. date 05/2026; A240342, A240347, A240385, A240391, exp. date 06/2026; NDC 70069-101-05; A240326, exp. date 05/2026

Distribution pattern

U.S. Nationwide

drug · product 2 of 5

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)

D-0355-2025

Recall number: D-0355-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Quantity: 997 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: Media fill with bacterial contamination

Code information

NDC 70069-381-01; A240467A, exp. date 07/2026; NDC 70069-381-10; A240467C, exp. date 07/2026

Distribution pattern

U.S. Nationwide

drug · product 3 of 5

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

D-0356-2025

Recall number: D-0356-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Quantity: 4956 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: Media fill with bacterial contamination

Code information

A240467B, exp. date 07/2026

Distribution pattern

U.S. Nationwide

drug · product 4 of 5

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)

D-0357-2025

Recall number: D-0357-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Quantity: 23,960 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: Media fill with bacterial contamination

Code information

NDC 68001-581-41; A240482A, exp. date 08/2026; NDC 68001-581-48; A240482B, exp. date 08/2026

Distribution pattern

U.S. Nationwide

drug · product 5 of 5

Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

D-0358-2025

Recall number: D-0358-2025
Initiated: March 21, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Somerset Therapeutics Private Limited
Quantity: 240 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: Media fill with bacterial contamination

Code information

A240482D, exp. date 08/2026

Distribution pattern

U.S. Nationwide