Manufacturer
35 recalls in our database name Breckenridge Pharmaceutical, Inc. as the manufacturing or recalling firm.
Of the 35 recalls from Breckenridge Pharmaceutical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Duloxetine Delayed-Release Capsules, USP, 60 mg, are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit. 359,676 bottles affected.
Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit.
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 60mg due to the presence of N-nitroso-duloxetine impurity above FDA recommended limits. The affected product was distributed nationwide.
Breckenridge Pharmaceutical is recalling 7,389 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended limit.
Philips North America is recalling the IntelliVue Patient Monitor MX550 over a potential issue where the monitors did not alarm.
Breckenridge Pharmaceutical is recalling 172,263 bottles of Duloxetine Delayed-Release Capsules 60 mg because N-nitroso-duloxetine was above the 12.5 ppm safety assessment limit.
Duloxetine Delayed-Release Capsules, USP, 30 mg, lot 240927C, made for Quallent Pharmaceuticals, are recalled because N-nitroso-duloxetine was above the proposed interim limit. 3,591 bottles are affected.
Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 bottles affected.
Duloxetine Delayed-Release Capsules USP 60 mg distributed by Breckenridge are being recalled because N-nitroso-duloxetine was present above the safety assessment limit. 1,829 bottles affected.
Duloxetine Delayed-Release Capsules 40 mg are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 12,242 bottles are affected.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules nationwide due to elevated levels of a nitrosamine-related impurity that exceed the FDA's interim safety limit. The affected lots include bottles with expiration dates in April 2027.
Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.
Breckenridge Pharmaceutical is recalling Duloxetine 30 mg capsules distributed nationwide due to a nitrosamine impurity above acceptable limits. Consumers should consult their doctor about their medication.
Breckenridge Pharmaceutical is recalling 11,125 bottles of Duloxetine 20mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits. The impurity was detected during quality control testing.
Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.
Breckenridge Pharmaceutical recalls 11,100 bottles of Duloxetine 60mg capsules distributed nationwide due to the presence of N-nitroso-duloxetine impurity exceeding FDA recommended interim limits from manufacturing deviations.
Breckenridge Pharmaceutical is recalling 163,883 bottles of Duloxetine 30mg capsules nationwide due to N-nitroso-duloxetine impurity above FDA-recommended limits.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.
Breckenridge Pharmaceutical is recalling 7,107 bottles of Duloxetine 20mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA interim limits. No illnesses have been reported.
Breckenridge Pharmaceutical recalls Duloxetine 60mg capsules nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. Affected lots had current good manufacturing practice (CGMP) deviations.
Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.
Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.
Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.
Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.
Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.