CutisPharma Recalls FIRST Omeprazole Kit Due to Labeling Error
CutisPharma recalls 5,904 kits of FIRST Omeprazole due to a label error stating the wrong strength. Check your lot number and expiration date.
Use caution until it’s fixed
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Contact the company
What happened, in plain English
CutisPharma, Inc. is recalling 5,904 kits of FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit because the package insert incorrectly lists the strength as 3mg per mL instead of the correct 2mg per mL. This labeling error could lead to confusion regarding the medication's potency. The recall covers kits manufactured for CutisPharma with NDC# 65628-070-03, Lot # E1396, and an expiration date of 08/2018. Read more at govinfonow.com/recall/42285-cutispharma-recalls-first-omeprazole-kit-due-to-labeling-error.
Source Summary by GovInfoNow · govinfonow.com/recall/42285-cutispharma-recalls-first-omeprazole-kit-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-0139-2017
Cite this page
“CutisPharma Recalls FIRST Omeprazole Kit Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42285-cutispharma-recalls-first-omeprazole-kit-due-to-labeling-error. Based on FDA recall #D-0139-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0139-2017%22&limit=1).
Why it’s dangerous
The package insert contains an error in the Description section, stating the strength is 3mg per mL when it should be 2mg per mL. This discrepancy could cause healthcare providers or patients to misunderstand the actual concentration of the omeprazole suspension.
Who’s affected
Patients who have been prescribed or received the FIRST Omeprazole compounding kit from CutisPharma nationwide. Specifically, those with kits containing Lot # E1396 and an expiration date of 08/2018.
How to tell if you have this one
Look for the FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit, 3 OZ size. Check the package for NDC# 65628-070-03, Lot # E1396, and an expiration date of 08/2018.
- Brand
CutisPharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0138-2017 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05; Lot #: E1414, Exp. 08/2018 | 8,748 kits |
| D-0139-2017 | FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03; Lot #: E1396, Exp. 08/2018 | 5904 kits |
What to do — step by step
Check Your Kit Details
Verify if your kit matches NDC# 65628-070-03, Lot # E1396, and Exp. 08/2018.
Contact Your Provider
Consult your healthcare provider or pharmacist about the labeling discrepancy and next steps.
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 11 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-0139-2017 (October 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0139-2017 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.