CLASS II ONGOING Drug recall · Reported 10 Jun 2026 · FDA Enforcement Report
Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USA
Asclemed USA is recalling Duloxetine DR Capsules, 30 mg, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA, distributed nationwide in the US. The recall was initiated on 14 May 2026 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-0555-2026
- FDA event ID
- 99019
- Recalling firm
- Asclemed USA, Torrance, CA
- Brand
- Duloxetine
- Manufacturer
- Asclemed USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2026
- FDA classified
- 2 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 14 May 2026 | Recall initiated by company | |
| 2 Jun 2026 | Classified by FDA | +19 days |
| 10 Jun 2026 | 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 FDA acceptable intake 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 DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Which lots are affected?
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Where was it sold?
US Nationwide.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Asclemed USA
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|---|---|---|---|---|---|
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |
| Drug | CLASS II | Accucaine, Kit contains: Lidocaine HCl Injection recalledAccucaine | Asclemed USA | Sterility | Nationwide |
| Drug | CLASS III | Asclemed USA products recalled | Asclemed USA | Other | AL, CA, LA |
| Drug | CLASS II | Estriol, USP, (Micronized) recalled by Asclemed USA | Asclemed USA | Potency & Assay | CA |
Other Duloxetine recalls
All 57| 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 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 |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 20 mg recalled by Ajanta PharmaDuloxetine | Ajanta Pharma | Nitrosamine Impurity | Nationwide |