Recalls / Class II

Class IID-0568-2025

Product

Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,

Affected lot / code info

Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/2026.

Why it was recalled

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Recalling firm

Firm

Direct Rx

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828

Distribution

Quantity

875 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2025-03-07

FDA classified

2025-08-04

Posted by FDA

2025-08-13

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0568-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.