Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Read the official notice →- Date
- 2025-07-16
- Country
- United States
- Brand
- Breckenridge Pharmaceutical
- Product
- Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles,…
- Classification
- Class II
- Units
- U.S. Nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Breckenridge Pharmaceutical recalls
- 2025-09-17
USBreckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
- 2025-08-20
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- 2025-08-13
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- 2025-04-30
- US
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L.,…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- 2025-04-09
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical…
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
- 2025-03-19
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Other drugs & medical recalls in the United States
- 2025-07-16
- US
Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric…
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's…
- US
Baxter Healthcare Corporation recalls Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200…
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched…
- US
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Macleods Pharmaceuticals Ltd recalls Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods…
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- 2025-07-09
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Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA,…Official notice → - US
Becton, Dickinson and Company, BD Bio Sciences recalls REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
FDA · DeviceBecton, Dickinson and Company, BD Bio SciencesUS: Arkansas, Arizona, California, Colorado, Connecticut, District of…Official notice →