API RED LIST Who's out. Who's in.
WARNING LETTER · 02 NOV 2026STERILE LINE STOPPED FOR USFEI 3004086192 · Dabhel, Daman

USV, Daman: the vial line is out

FDA found airflow and aseptic failures on the injectable filling lines. USV told the agency it stopped commercial production on that line for the US market.

Is your product on this list?

Products at risk. Who's in.

FDA labellabel names this site
MOLECULE FORM SOLD IN THE US BY LINK TO SITE RISK WHO'S IN Action
Octreotide acetate Injection, vials Avet FDA LABEL LINE STOPPED 14 API (12 US DMF) · 25 FDF See who's in
Felodipine Extended-release tablets Avet FDA LABEL SAME SITE 23 API (13 US DMF) · 40 FDF See who's in
Glyburide-metformin Tablets Avet, repackagers FDA LABEL SAME SITE 26 API (12 US DMF) · 7 FDF See who's in
Doxycycline Tablets, delayed-release tablets Avet, Chartwell FDA LABEL SAME SITE 23 API (16 US DMF) · 51 FDF See who's in
Desipramine Tablets Avet, Chartwell FDA LABEL SAME SITE 9 API (6 US DMF) · 3 FDF See who's in
Naratriptan Tablets Avet FDA LABEL SAME SITE 10 API (6 US DMF) · 21 FDF See who's in
Acitretin Capsules Mylan FDA LABEL SAME SITE 10 API (8 US DMF) · 20 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. Smoke studies on the ISO 5 vial filling line showed air swirling and moving upward instead of flowing one way over open product.
  2. Operators reached over sterile equipment during interventions. The line meant to work as a RABS had design gaps.
  3. A conveyor on the filling line blocked clean airflow to open sterile bottles on their way to filling.
  4. No action limits for visible particles in injections, and no split between particles from the product and from outside.
Timeline

How it got here

BEFORE 28 MAR 2026 Batches released without an adequate check for visible particles
7–17 APR 2026 FDA inspection, Form 483 issued
8 MAY 2026 USV responds, production on the line suspended
2 NOV 2026 Warning Letter. By then USV had dropped the line for the US
NEXT Response due in 15 business days. Import Alert possible

USV's vial line is out. 14 octreotide API makers are in.

Open the list on API-FDF

Sources