Duloxetine Prescription Capsules Recalled Nationwide for Nitrosamine Impurity
Golden State Medical Supply is recalling Duloxetine 30mg capsules nationwide due to contamination with N-nitroso-duloxetine, a nitrosamine impurity above the FDA's proposed safety limit. Affected lots expire January 31, 2025.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—nitrosamine impurity above safety limits—is a risk-of-harm concern but remains theoretical without adverse health reports, meeting the criterion for Score 3 (High).
Plain-English summary
Golden State Medical Supply Inc. is recalling Duloxetine (Duloxetine Hydrochloride) 30mg delayed-release capsules nationwide due to the presence of N-nitroso-duloxetine, a nitrosamine drug substance related impurity (NDSRI), in excess of the FDA's proposed interim limit. The affected lots are GS045371 and GS045910, both expiring January 31, 2025.
Nitrosamines are substances that may have carcinogenic potential. The impurity was found to exceed established safety thresholds during manufacturing quality control. This recall addresses a manufacturing and quality control deviation rather than a safety incident with reported patient harm.
The recall affects Duloxetine capsules distributed nationwide in the United States in two package sizes: 30-capsule bottles (NDC 60429-165-30) and 90-capsule bottles (NDC 60429-165-90). Approximately 55,804 units are affected.
Consumers and healthcare providers who have the affected medication should consult their healthcare provider about the recall before stopping the medication, as abrupt discontinuation may cause withdrawal symptoms.
The recalled product
- Product
- DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Brand
- DULOXETINE
- Manufacturer
- Golden State Medical Supply Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot: a) GS045371
- Exp: 01/31/2025
- b) GS045910
- Exp. 01/31/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · DULOXETINE
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- ModerateDuloxetine Delayed-Release Capsules Recalled for Impurity Above FDA Limit
FDA (Drugs) · 2026-05-13
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
Same manufacturer · Golden State Medical Supply Inc.
See all →- SevereGolden State Medical Supply Recalls Prasugrel Tablets for Failed Dissolution
FDA (Drugs) · 2026-09-09
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- ModerateNiacin extended-release tablets failed dissolution testing at 24 hours
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
Same hazard · nitrosamine impurity
See all →- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
Similar recalls
- HighDuloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits
FDA (Drugs) · 2024-05-15
- HighDuloxetine antidepressant recall for chemical impurity above FDA limit
FDA (Drugs) · 2025-01-01
- HighPrescription Duloxetine Capsules Recalled for Nitrosamine Impurity
FDA (Drugs) · 2025-04-09
- HighDuloxetine 30mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-03-19
- ModerateDuloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
FDA (Drugs) · 2025-04-30
- HighDuloxetine 20mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-10-23