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.
Read the official notice →- Date
- 2025-11-05
- Country
- United States
- Brand
- Breckenridge Pharmaceutical
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-17
USBreckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-05-13
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Breckenridge 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
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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
- 2025-09-17
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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.
- 2025-08-20
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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
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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
Other drugs & medical recalls in the United States
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Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited,…
CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
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Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100…
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Amerisource Health Services LLC recalls Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packaging,…
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Samsung Bioepis Co., Ltd. recalls HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC,…
Lack of Assurance of Sterility.
FDA · DrugSamsung Bioepis Co., Ltd.Distributed only to one warehouse in NJ. with no further distributionOfficial notice → - 2025-10-29
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