Reported Apr 9, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa…
Breckenridge Pharmaceutical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc. · 200 Connell Dr Ste 4200 · Berkeley Heights, NJ · 07922-2805
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle
- Manufactured byTowa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain
- Distributed byBreckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10
- Lot codes and dates
Lot 240909CExp Date 03/31/2027
- Amount recalled
- 14,863 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Breckenridge Pharmaceutical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.