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Class II: temporary or reversible health riskOngoing

Baxter Healthcare Clindamycin Phosphate in 0 Recall

Clindamycin Phosphate in 0

Baxter Healthcare Corporation · Deerfield, IL

Risk level
Class II
Reported by FDA
Sep 9, 2026
Recall ID
D-0816-2026
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Clindamycin Phosphate in 0 starting Aug 6, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0816-2026 on Sep 9, 2026. Reason: CGMP Deviations. Status: Ongoing.

Why it was recalled

CGMP Deviations

Product description

Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.

Lot numbers, UPCs & expiration codes

Lot # NC193689, Exp Date: 10/16/2027.

Where it was sold

US Nationwide; Puerto Rico; and Chile.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0816-2026
Classification
Class II
Status
Ongoing
Recall initiated
Aug 6, 2026
FDA report date
Sep 9, 2026
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corporation

Original FDA data

Every field from FDA enforcement report D-0816-2026, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Ongoing
Country
United States
Event ID
99500
Address
1 Baxter Pkwy
Code information
Lot # NC193689, Exp Date: 10/16/2027.
Postal code
60015-4625
Report date
Sep 9, 2026
Product type
Drugs
Recall number
D-0816-2026
Classification
Class II
Recalling firm
Baxter Healthcare Corporation
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
Distribution pattern
US Nationwide; Puerto Rico; and Chile.
Recall initiation date
Aug 6, 2026
Initial firm notification
Letter
Center classification date
Aug 28, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0816-2026, published Sep 9, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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