Breckenridge Recalls Duloxetine 60mg Due to Foreign Capsule
Breckenridge recalls Duloxetine 60mg capsules due to a foreign omeprazole capsule. Check lot 142391, exp 10/2016.
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Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
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What happened, in plain English
Breckenridge Pharmaceutical is recalling one bottle of Duloxetine Delayed-release Capsules, USP, 60 mg because it contains a foreign capsule identified as omeprazole 10 mg. The affected item was manufactured by Laboratorios Dr. Esteve and distributed nationwide. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/43423-breckenridge-pharmaceutical-inc-recalls-duloxetine-delayed-release-capsules-usp-60.
Source Summary by GovInfoNow · govinfonow.com/recall/43423-breckenridge-pharmaceutical-inc-recalls-duloxetine-delayed-release-capsules-usp-60 · Updated October 11, 2026 · FDA enforcement record: FDA #D-0181-2016
Cite this page
“Breckenridge Recalls Duloxetine 60mg Due to Foreign Capsule.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43423-breckenridge-pharmaceutical-inc-recalls-duloxetine-delayed-release-capsules-usp-60. Based on FDA recall #D-0181-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0181-2016%22&limit=1).
Why it’s dangerous
The presence of a foreign medication (omeprazole) in a bottle intended for duloxetine creates a risk of accidental ingestion. This could lead to unintended side effects, allergic reactions, or adverse drug interactions for the patient.
Who’s affected
Patients who have been prescribed Duloxetine 60 mg capsules from this specific lot may be affected. The risk is particularly relevant to those who cannot take omeprazole due to allergies or drug interactions.
How to tell if you have this one
Check if you have a 1000 count bottle of Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only. Look for NDC: 51991-748-10 and Lot #: 142391 with an expiration date of 10/2016. The bottle was manufactured by Laboratorios Dr. Esteve, S.A., Barcelona, Spain.
- Brand
Breckenridge Pharmaceutical- Category
Drug
What to do — step by step
Stop taking the medication
Do not consume any capsules from the affected bottle due to the risk of ingesting foreign omeprazole.
Contact your pharmacist or doctor
Reach out to your healthcare provider for guidance on replacing the medication and managing your treatment plan.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0181-2016 (October 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0181-2016 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.