Reported Jan 1, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. 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 · 15 Massirio Dr Ste 201 · Berlin, CT · 06037-2352
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr
- byTowa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist
- byBreckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922
- Lot codes and dates
Lot # 222205Cexp. date 11/2025
- Amount recalled
- 163,883 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA 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.