AvKARE Recalls Duloxetine Capsules Due to Impurities
AvKARE recalls specific lots of Duloxetine Delayed-release Capsules USP, 20 mg due to slightly elevated levels of phthalic acid impurities.
Recall notice
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Contact the company
What happened, in plain English
AvKARE Inc. is recalling Duloxetine Delayed-release Capsules USP, 20 mg because the product contains slightly elevated levels of phthalic acid, failing impurity specifications. The recall affects 274 cartons distributed nationwide in the USA. The record does not specify a remedy or consumer action steps. Read more at govinfonow.com/recall/41155-avkare-recalls-duloxetine-capsules-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/41155-avkare-recalls-duloxetine-capsules-due-to-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-0055-2018
Cite this page
“AvKARE Recalls Duloxetine Capsules Due to Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41155-avkare-recalls-duloxetine-capsules-due-to-impurities. Based on FDA recall #D-0055-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0055-2018%22&limit=1).
Why it’s dangerous
The recalled capsules failed impurity specifications by containing slightly elevated levels of phthalic acid. The provided record does not describe the specific health risks or injury mechanisms associated with this chemical impurity.
Who’s affected
Patients who have been prescribed or purchased Duloxetine Delayed-release Capsules USP, 20 mg from pharmacies across the United States between the manufacturing date and the recall announcement. The specific affected units are those with Lot number 18103.
How to tell if you have this one
Check your medication bottle for the brand AvKARE, Inc., manufactured in Pulaski, TN. Look for NDC 50268-283-15, Lot number 18103, and an expiration date of 11/18. The product is a unit dose blister pack containing 50 capsules (5 x 10) with UPC 5026828311.
- Brand
AvKARE- Product
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0055-2018 (October 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0055-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.