duloxetinedrugHigh PriorityActive

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-

duloxetine Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748- recalled by FDA. CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

By RecallRadar Editorial Team

Sourced from FDA. Last reviewed March 4, 2026.

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: November 24, 2025
Last reviewed by RecallRadar: March 4, 2026

What You Should Do

1## Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748- Agency: FDA | Category: drug Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit What to do:
2Stop using the product if your lot/model matches.
3Check the FDA notice for specifics.
4Follow remedy instructions.

Open Official Recall Notice Get Alerts for duloxetine Devices

What's Being Recalled

Quoted source excerpt from the official notice.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.

#	Model
1	Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

Frequently Asked Questions

Is my duloxetine device affected?

Check the affected models section on this page. The official notice currently lists Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027..

What is the remedy for this recall?

## Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748- Agency: FDA | Category: drug Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: duloxetine recall hub and Food & Drug recall hub.