FDA (Drugs) recall action 91556
The FDA (Drugs) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.
Subpotent Drug
The agency’s own wording, quoted from the enforcement report.
IBSA Pharma Inc. recalled TIROSINT levothyroxine sodium lot 220853 nationwide due to subpotency. The oral solution may contain less active ingredient than labeled, potentially affecting thyroid hormone replacement therapy.
IBSA Pharma has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Affected lots 220418 and 220560 may contain insufficient active ingredient for proper thyroid hormone replacement therapy.
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency—some doses contain insufficient active ingredient. Patients should contact their pharmacist or doctor to verify their medication.
IBSA Pharma has recalled one lot of TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. The product contained less active ingredient than labeled.
IBSA Pharma Inc. has recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency. Some doses may contain less active ingredient than labeled. Patients should contact their healthcare provider.
IBSA Pharma voluntarily recalled TIROSINT levothyroxine sodium oral solution nationwide due to subpotency concerns. Affected lots are 220416 (Exp. 10/2023) and 221053 (Exp. 4/2024).
IBSA Pharma Inc. voluntarily recalled specific lots of TIROSINT (levothyroxine sodium) Oral Solution nationwide due to subpotency. The affected medication contains less active ingredient than labeled.
IBSA PHARMA is recalling TIROSINT (levothyroxine sodium) oral solution due to subpotency in specific batches. The affected product may contain less active ingredient than labeled.
IBSA PHARMA INC is recalling TIROSINT oral solution (Lot #220855) nationwide due to insufficient potency of levothyroxine sodium. The defective lot was voluntarily recalled after manufacturer discovery.
IBSA Pharma is recalling TIROSINT levothyroxine sodium oral solution nationwide due to subpotent drug content. The recall affects lots 220413 and 220964.
IBSA Pharma Inc. recalls TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotent formulation containing less active ingredient than labeled.
IBSA Pharma has recalled two lots of TIROSINT levothyroxine sodium oral solution nationwide because they contain less active ingredient than labeled. The affected lots are 220409 (expiring 10/2023) and 220956 (expiring 03/2024).
TIROSINT (levothyroxine sodium) oral solution has been recalled nationwide by IBSA Pharma Inc. due to subpotency, with the affected medication containing less active ingredient than labeled.
IBSA Pharma Inc. is recalling TIROSINT (levothyroxine sodium) oral solution nationwide due to subpotency. Two lot numbers are affected: Lot #220407 (Exp. 10/2023) and Lot #220960 (Exp. 03/2024).
IBSA Pharma is recalling certain lots of TIROSINT (levothyroxine sodium) oral solution nationwide because the product contains less active ingredient than labeled. Patients using affected lots may not receive adequate thyroid hormone replacement.