Food, drugs, devices › Preferred Pharmaceuticals, Inc.
Drug recall: Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Preferred Pharmaceuticals, Inc. (Anaheim, CA) initiated this drug recall on 10 May 2024; FDA lists 1 product record under event 94648, classified Class II.
FDA defines Class II as 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. 71% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Preferred Pharmaceuticals, Inc. has 32 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Preferred Pharmaceuticals, Inc., Anaheim, CA.
Reason for recall
"CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit"
Distribution
"Product distributed to CA, FL, OK, KS and CT"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0505-2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 | 66 bottles of 30 tablets | Class II | Ongoing | 29 May 2024 |
Context
Other enforcement events for Preferred Pharmaceuticals, Inc.
All 32 events for Preferred Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Product distributed to CA, FL, OK, KS and CT"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.