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WARNING LETTER · 29 SEP 2026RECALLFEI 1416980 · Round Lake, IL

Baxter Round Lake: cephalosporin on the wrong side of the wall

FDA found cephalosporin, again and again, in the part of Baxter's Illinois plant that fills non-beta-lactam IV bags. Ten premixed injectables were already recalled in August.

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Products at risk. Who's in.

Recalledin the firm's recall notice
MOLECULE FORM SOLD IN THE US BY LINK TO SITE RISK WHO'S IN Action
Vancomycin Premix IV bag (Galaxy), frozen Baxter RECALLED RECALLED 17 API (12 US DMF) · 38 FDF See who's in
Clindamycin Premix IV bag (Galaxy) Baxter RECALLED RECALLED 36 API (30 US DMF) · 34 FDF See who's in
Daptomycin Premix IV bag (Galaxy), frozen Baxter RECALLED RECALLED 13 API (7 US DMF) · 28 FDF See who's in
Dexmedetomidine Premix IV bag (Galaxy) Baxter RECALLED RECALLED 10 API (10 US DMF) · 38 FDF See who's in
Pantoprazole Premix IV bag (Galaxy), frozen Baxter RECALLED RECALLED 54 API (36 US DMF) · 35 FDF See who's in
Amiodarone Premix IV bag (Nexterone) Baxter RECALLED RECALLED 21 API (14 US DMF) · 19 FDF See who's in
Nicardipine Premix IV bag (Cardene IV) Baxter, under Chiesi license RECALLED RECALLED 13 API (13 US DMF) · 5 FDF See who's in
Famotidine Premix IV bag (Galaxy) Baxter RECALLED RECALLED 27 API (20 US DMF) · 5 FDF See who's in
Vasopressin Premix IV bag Baxter RECALLED RECALLED 3 API (2 US DMF) · 4 FDF See who's in
Insulin human Premix IV bag (Myxredlin) Baxter RECALLED RECALLED 2 API (2 US DMF) · 9 FDF See who's in

FDA often redacts product names in its letters. Rows marked "FDA label" come from openFDA drug labels that name this site. "Who's in" counts manufacturers of the same molecule in the API-FDF database; names and contacts are inside.

What FDA found
  1. Since January 2025 Baxter's own swabs kept finding cephalosporin on the non-beta-lactam side of the building, in several areas.
  2. Containment rested on a wall Baxter called fully sealed and on dedicated HVAC. FDA says the design has to rule out any crossover by air, people, materials or equipment.
  3. Finished batches were checked for beta-lactam with one unit per batch, whatever the batch size.
  4. Several failing cephalosporin samples were thrown away before anyone analyzed them.
  5. Data Baxter shared with FDA during recall talks showed more cephalosporin contamination events in the non-beta-lactam area.
Timeline

How it got here

JAN 2025 Environmental monitoring starts finding cephalosporin outside the beta-lactam area
23 MAR – 2 APR 2026 FDA inspection at Round Lake, Form 483
23 APR 2026 Baxter responds to the 483
6 AUG 2026 Urgent drug recall of premixed bags over possible beta-lactam contamination. Lots shipped since 3 Feb 2025
29 SEP 2026 Warning Letter
20 OCT 2026 FDA posts the letter

Baxter's premix lots are recalled. 38 vancomycin injection makers are in.

Open the list on API-FDF

Sources

Related analysis Baxter Warning Letter Ends a $50M Cephalosporin Line With 60% Margins