Limited official informationFDA Drug Enforcement ReportsRecall date: Jul 8, 2026

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THY...

Full official product description

Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Identifiers to compare

NDC 0143-9341-01

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE Gm...	Lot #: CB0046, Exp. Date 06/2027	74 units	D-0714-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

U.S. Food and Drug Administration authoritative

Official scope

Distribution reported by the agency

Nationwide within the United States

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.