DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distr
Summary
The FDA issued a Class II for DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60 by Direct Rx. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Details
Source
Drug Recall
External ID
D-0617-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
Product Description
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Lot/Code Info: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Quantity Affected: 263 Bottles
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-22
Company
Dawsonville, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Direct Rx has 31 FDA actions in our database, including 31 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Direct Rx) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Direct Rx have FDA actions?
Direct Rx has 31 FDA actions in our database, including 31 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0617-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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