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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97710

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 10, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Samsung Bioepis Co., Ltd.

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

1 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 1

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01.

D-0099-2026
Recall number
D-0099-2026
Initiated
October 10, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Samsung Bioepis Co., Ltd.
Quantity
5,518 packs (11,036 Syringes) 2 syringes/carton)

App-derived interpretation

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.

Code information

Lot: F2505017, Expiry: 24-Jan-2027

Distribution pattern

Distributed only to one warehouse in NJ. with no further distribution