Wells Pharma recalls fentanyl citrate injectable solution (NARCOTIC, Cii) due to cGMP deviations. Products with specific NDC numbers and expiration dates are affected. Consumers should contact Wells Pharma for details.
cGMP deviations.
Wells Pharma has recalled certain fentanyl citrate injectable solutions because of manufacturing quality control issues. This recall affects specific batch numbers with expiration dates up to May 2026. The issue could lead to unsafe drug products if used without proper quality checks.
The recall is due to cGMP deviations, which are manufacturing quality control issues that could result in unsafe drug products. These deviations may affect the purity or potency of the medication, potentially leading to adverse effects if used without proper quality checks.
Healthcare professionals who use the fentanyl citrate injectable solution for medical purposes are likely affected. Patients receiving this medication under medical supervision may also be impacted.
Check for the product name 'Fentanyl Citrate Injectable Solution' with NDC numbers listed in the recall notice. The affected batches have specific expiration dates ranging from May 2026 to April 2026.
Reach out to Wells Pharma directly for specific batch numbers and instructions on how to handle the recalled product.
The hazard is cGMP deviations, which are manufacturing quality control issues that could result in unsafe drug products.
Check the NDC numbers listed in the recall notice and compare with the expiration dates provided (up to May 2026).
The recall does not specify a stop-use instruction, so you should contact Wells Pharma for specific guidance.
We’ve drafted a message you can send Wells Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0503-2026 — Wells Pharma Wells Pharma Hello, I own a Wells Pharma that is covered by recall D-0503-2026 from Wells Pharma. 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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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.
