CLASS II Drug recall · Reported 3 Jul 2024 · FDA Enforcement Report
Duloxetine Delayed-Release Capsules, USP, 30mg recalled
Golden State Medical Supply is recalling Duloxetine Delayed-Release Capsules, USP, 30mg, distributed nationwide in the US. The recall was initiated on 13 May 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0568-2024
- FDA event ID
- 94639
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2024
- FDA classified
- 25 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 13 May 2024 | Recall initiated by company | |
| 25 Jun 2024 | Classified by FDA | +43 days |
| 3 Jul 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Duloxetine Delayed-Release Capsules, USP, 30mg recalled?
Yes. Golden State Medical Supply recalled Duloxetine Delayed-Release Capsules, USP, 30mg on 13 May 2024. The recall is Class II and its status is Terminated. Recall number D-0568-2024.
Why was it recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Which lots are affected?
Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
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Other Duloxetine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine | Asclemed USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine | Breckenridge Pharmaceutical | Nitrosamine Impurity | Nationwide |