Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc…
Reason Subpotent drug
Thyroid Medication Recalls
Recalls of levothyroxine and other thyroid hormone replacement drugs, often over sub-potency.
226 recalls in this category, newest first.
Class II · Moderate risk Completed
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC…
Reason Failed Stability Specifications
Class II · Moderate risk Completed
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs…
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries…
Reason Failed Impurities/Degradation Specifications.
Class II · Moderate risk Terminated
Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury…
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Ongoing
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064…
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is…
Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601…
Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 88 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 125 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA…
Reason Subpotent Drug
Class II · Moderate risk Terminated
LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste…
Reason Lack of sterility assurance
Class II · Moderate risk Terminated
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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