Breckenridge Pharmaceutical, Inc recalls Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge
Breckenridge Pharmaceutical recalls 20mg Omeprazole Delayed-Release Capsules due to stability testing showing unknown impurities. This may affect drug safety for patients using prescription medication.
Recall notice
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Contact the company & request your remedy
What happened, in plain English
Breckenridge Pharmaceutical is recalling 20mg Omeprazole Delayed-Release Capsules because stability testing found unknown impurities. This could affect the safety of the medication for patients who need it. Read more at govinfonow.com/recall/36481-breckenridge-omeprazole-capsules-recall-impurities-risk-in-drug-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/36481-breckenridge-omeprazole-capsules-recall-impurities-risk-in-drug-stability · Updated October 4, 2026 · FDA enforcement record: FDA #D-0308-2021
Cite this page
“Breckenridge Omeprazole Capsules Recall: Impurities Risk in Drug Stability.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36481-breckenridge-omeprazole-capsules-recall-impurities-risk-in-drug-stability. Based on FDA recall #D-0308-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0308-2021%22&limit=1).
Why it’s dangerous
The recall is based on stability testing showing unknown impurities in the medication. This could mean the drug might not be safe for patients using it as prescribed, though the exact risk isn't specified in the recall notice.
Who’s affected
Patients with a prescription for Omeprazole Delayed-Release Capsules, 20mg, 1000-count bottles. Those who have the specific lot number 191659 from the manufacturer's distribution are most at risk.
How to tell if you have this one
Check for the product name 'Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles' with the lot number 191659 and expiration date 05/2021. The product is only available by prescription.
- Brand
Breckenridge- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 191659 and expiration date 05/2021 on the bottle.
Questions people ask
Is this product safe to use?
The recall states that stability testing found unknown impurities, but the exact safety risk isn't specified. Patients should contact their healthcare provider for advice.
How can I tell if I have the recalled product?
Check for the product name 'Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles' with the lot number 191659 and expiration date 05/2021.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to stop using the product.
Contact Breckenridge
We’ve drafted a message you can send Breckenridge to request your refund or repair — edit it as you like.
Subject: Recall D-0308-2021 — Breckenridge Breckenridge Hello, I own a Breckenridge that is covered by recall D-0308-2021 from Breckenridge. 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-0308-2021 (March 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0308-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.