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
FDA Drug Recalls
17,898 recalls, newest first
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 III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by…
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by…
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class III · Low risk Terminated
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland…
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk Terminated
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML)…
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Ongoing
Hand Sanitizer, HSANI4LI, (Isopropyl Alcohol), 75% Topical Solution, packaged in 4 L bottles, Thermo Fisher Scientific: Janssen…
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…
Class II · Moderate risk Ongoing
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo…
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer…
Class II · Moderate risk Terminated
Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED…
Reason Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack…
Class II · Moderate risk Terminated
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical…
Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk Terminated
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch…
Reason Short Fill