Baxter Recalls Metronidazole Injection Due to Cloth Fiber Contamination
Baxter Healthcare recalls 334,560 bags of Metronidazole Injection USP due to cloth fiber particulate matter. Check lot P339135.
Stop using this now
Presence of Particulate Matter: identified as a cloth fiber.
Contact the company
What happened, in plain English
Baxter Healthcare Corp. is recalling one lot of Metronidazole Injection USP because it contains a foreign object: a cloth fiber. This contamination poses a risk to patients who receive the medication intravenously. The recall affects 334,560 bags distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/43213-baxter-recalls-metronidazole-injection-due-to-cloth-fiber-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/43213-baxter-recalls-metronidazole-injection-due-to-cloth-fiber-contamination · Updated October 11, 2026 · FDA enforcement record: FDA #D-0863-2016
Cite this page
“Baxter Recalls Metronidazole Injection Due to Cloth Fiber Contamination.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43213-baxter-recalls-metronidazole-injection-due-to-cloth-fiber-contamination. Based on FDA recall #D-0863-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0863-2016%22&limit=1).
Why it’s dangerous
The presence of particulate matter, specifically a cloth fiber, in an injectable drug can cause serious harm if introduced into the bloodstream. Foreign particles can lead to blockages, inflammation, or other severe medical complications during infusion.
Who’s affected
Patients receiving Metronidazole Injection at hospitals or clinics across the United States and Puerto Rico are affected. Healthcare providers administering this specific lot are most at risk of exposing patients to the contamination.
How to tell if you have this one
Check for Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL) in a 100mL Sterile Single Dose Container bag. Look for Product Code 2B3421, NDC 0338-1055-48, and Lot # P339135 with an expiration date of 08/31/2017.
- Brand
Baxter- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity | Class | NDC |
|---|---|---|---|---|
| D-0861-2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.; Lot #: P337857, Exp 07/31/16 | 282,080 bags | Class II | 0338-0553-11, 0338-0553-18 |
| D-0862-2016 | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.; Lot #: P328997, Exp 01/31/2016 | 273,520 bags | Class I | 0338-0553-11, 0338-0553-18 |
| D-0863-2016 | Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.; Lot #: P339135, Exp 08/31/2017 | 334,560 bags | Class I | 0338-1055-48 |
| D-0864-2016 | CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.; Lot #: P333930, Exp 05/31/2017 | 7,436 bags | Class I | 0338-1142-03, 0338-1144-03, 0338-1113-04, 0338-1145-03, 0338-1115-04, 0338-1147-03, 0338-1123-04, 0338-1125-04, 0338-1148-03, 0338-0202-01, 0338-0202-06, 0338-0206-01, 0338-0206-04, 0338-0210-01, 0338-0210-06, 0338-0214-01, 0338-0214-04, 0338-7020-01, 0338-7020-06, 0338-7022-01, 0338-7022-06, 0338-7024-01, 0338-7024-04, 0338-7026-01, 0338-7026-06, 0338-7028-01, 0338-7028-04, 0338-7030-01, 0338-7030-06, 0338-7032-01, 0338-7032-04, 0338-7034-01, 0338-7034-06, 0338-7036-01, 0338-7036-04 |
What to do — step by step
Stop Using the Product
Do not administer or use any bags matching the recalled lot number and product codes.
Contact Your Supplier
Reach out to your distributor or Baxter Healthcare for instructions on returning or disposing of the affected inventory.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0863-2016 (January 21, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0863-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.