Breckenridge 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.
Read the official notice →- Date
- 2025-09-17
- Country
- United States
- Brand
- Breckenridge Pharmaceutical
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L.,…
- Classification
- Class II
- Units
- AZ, IN, NJ
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-05-13
USBreckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles,…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-12-10
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe,…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- 2025-11-05
- US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC…
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
- 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
- 2025-07-16
- US
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
Other drugs & medical recalls in the United States
- 2025-09-17
- US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister…
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was…
- US
Zydus Pharmaceuticals (USA) Inc recalls Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by…
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- US
World Perfumes Inc. recalls Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle,…
Defective Container: broken or leaking bottles.
- US
Exela Pharma Sciences LLC recalls 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only,…
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- 2025-09-10
- US
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- US
CARIS LIFE SCIENCES recalls MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor…
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation