CLASS II ONGOING Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Duloxetine Delayed-Release Cap USP 30mg recalled
Preferred Pharmaceuticals is recalling Duloxetine Delayed-Release Cap USP 30mg, distributed in California, Connecticut, Florida, Kansas, Oklahoma. The recall was initiated on 10 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-0505-2024
- FDA event ID
- 94648
- Recalling firm
- Preferred Pharmaceuticals, Anaheim, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 21 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Antidepressants
Timeline
| 10 May 2024 | Recall initiated by company | |
| 21 May 2024 | Classified by FDA | +11 days |
| 29 May 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 N-nitroso-duloxetine impurity above FDA recommended 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 Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Where it was distributed
Product distributed to CA, FL, OK, KS and CT
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Which lots are affected?
Lot #: J2022G, Exp: 01/01/2025
Where was it sold?
Product distributed to CA, FL, OK, KS and CT
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.
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