CLASS II ONGOING Drug recall · Reported 13 Aug 2025 · FDA Enforcement Report

Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx

Direct Rx is recalling Duloxetine D/R, 30 mg, 30 Caps, distributed nationwide in the US. The recall was initiated on 7 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

Quantity recalled875 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0568-2025
FDA event ID: 97251
Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Mar 2025
FDA classified: 4 Aug 2025
Reported: 13 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Antidepressants

Timeline

7 Mar 2025	Recall initiated by company
4 Aug 2025	Classified by FDA	+150 days
13 Aug 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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,

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97251

This product is part of a recall event; the main page for the event is Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx.

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide

More recalls from Direct Rx

All 37

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
23 Apr 2025Drug	CLASS II	Ciprofloxacin Ophth Solution recalled by Direct Rx	Direct Rx	Packaging Defects	5 states
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide
12 Apr 2023Drug	CLASS II	Alprazolam C-IV, 0.5 mg, 30 Tabs recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide

Other Duloxetine D recalls

All 3

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide