FDANot Yet Classified · Drug · FDA event 99892; recall number pending · Recalled September 30, 2026

0 recall — Otsuka ICU Medical LLC

Agency report date: September 30, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: 0
Company / brand: Otsuka ICU Medical
Lot / serial / date codes: Lot #: 1042188, Exp. Date 10/31/2027
Distribution: Natinowide within the United States

Agency product description and boundaries

0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Affected product: 0 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Not yet assigned by the FDA — identified by FDA event ID 99892
Brand: All Otsuka ICU Medical recalls
Classification: Not Yet Classified
Units affected: 258480 bags
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

0 recall status

Companies & origin

Recalling firm location: Austin, TX, United States
Firm address: 3900 Howard Ln, 78728-6515

Identifying details (verbatim from the notice)

Product codes / lots: Lot #: 1042188, Exp. Date 10/31/2027
Distribution: Natinowide within the United States
Firm notified the public via: Letter
FDA event ID: 99892
Recall initiated: September 11, 2026
FDA report date: September 30, 2026

Other drug recalls from around the same time

Thyroid Tablets recall — VITRUVIAS THERAPEUTICS INCFDA · September 23, 2026
0 recall — B BRAUN MEDICAL INCFDA · September 16, 2026
Epinephrine Injection recall — American Regent, Inc.FDA · September 16, 2026
Dextrose Injection recall — Baxter Healthcare CorporationFDA · September 16, 2026
Glutathione 200 mg/mL recall — OPTIMAL BALANCE PHARMACYFDA · September 9, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 13, 2026 at 12:00 AM UTC.

Report a data error on this page