AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC
AVKARE recalls Duloxetine 20mg capsules due to slightly elevated phthalic acid levels. This may affect safety but does not cause immediate harm. Consumers should contact the manufacturer for details.
Lower-risk recall
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling Duloxetine Delayed-release Capsules (20mg, 50 capsules) because they contain slightly elevated levels of phthalic acid. This issue may pose a safety risk but does not typically cause immediate harm to users. Read more at govinfonow.com/recall/41155-avkare-duloxetine-capsules-recall-slightly-elevated-phthalic-acid-levels.
Source Summary by GovInfoNow · govinfonow.com/recall/41155-avkare-duloxetine-capsules-recall-slightly-elevated-phthalic-acid-levels · Updated October 7, 2026 · FDA enforcement record: FDA #D-0055-2018
Cite this page
“AVKARE Duloxetine Capsules Recall: Slightly Elevated Phthalic Acid Levels.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41155-avkare-duloxetine-capsules-recall-slightly-elevated-phthalic-acid-levels. 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
Slightly elevated levels of phthalic acid in the capsules could potentially cause safety concerns, though the exact risk is not clearly defined in the recall. This issue does not typically lead to immediate harm or serious injury.
Who’s affected
People who have purchased or received the specific Duloxetine capsules with the described lot number and UPC code are affected. Those using the medication for depression or other conditions are most at risk.
How to tell if you have this one
Check for the product name 'Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton' with the UPC 5026828311. The lot number is 18103 and expires November 18, 2018.
- 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
What to do — step by step
Check Product Details
Verify the product name, UPC code, and lot number to confirm if your capsules are affected.
Questions people ask
Is this recall dangerous?
The recall states slightly elevated levels of phthalic acid, but it does not specify immediate harm or serious injury risks.
What should I do if I have these capsules?
The recall does not provide specific action steps for consumers, only product identification details.
How can I confirm if my capsules are affected?
Check the product name, UPC code (5026828311), and lot number (18103) to see if they match the recalled items.
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0055-2018 — AVKARE Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, u Hello, I own a Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC that is covered by recall D-0055-2018 from AVKARE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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 qwen3:4b on October 7, 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.