Official recall notice

FDA DrugClass IINotable

FDA Recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA

Recall date
2026-07-01
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Product description

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Affected products

Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.

Verify with the official notice →
Share:

Related Recalls

2026-09-21 · FDA_DRUG
FDA Recall: Par Pharmaceutical: Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL)
Par Pharmaceutical
2026-09-21 · FDA_DRUG
FDA Recall: ICU Medical LLC: 0.9% Sodium Chloride Injection, USP, 100 mL
ICU Medical LLC
2026-09-16 · FDA_DRUG
FDA Recall: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Off
ImprimisRx NJ LLC
2026-09-16 · FDA_DRUG
FDA Recall: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharm
Ajanta Pharma USA Inc