Recall Ledger

Clindamycin Injection USP in 5% Dextrose recall (Baxter Healthcare Corporation)

DrugClass IIOngoing

Summary: Baxter Healthcare Corporation is recalling Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.. Reason: CGMP Deviations.

What is being recalled

Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.

Why

CGMP Deviations

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide; Puerto Rico; and Chile. (states named: Puerto Rico)

How to tell if yours is affected

Lot # NC193764, Exp Date: 10/18/2027; Lot # NC195232, Exp Date: 11/25/2027.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0808-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 6, 2026
ReportedSeptember 9, 2026
CompanyBaxter Healthcare Corporation
Company locationDeerfield, IL, United States
Initiated byVoluntary: Firm initiated
QuantityN/A

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Official FDA record