fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recall
FDA recall D-0508-2026 · initiated Apr 1, 2026
Wells Pharma of Houston LLC recalled fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride in Apr 2026 — an FDA Class II recall (D-0508-2026) because cGMP deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 50 syringes
Details
- Product
- fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
- Recalling company
- Wells Pharma of Houston LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Apr 1, 2026
- FDA report date
- May 6, 2026
Frequently asked
- Was fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recalled?
- Wells Pharma of Houston LLC recalled fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride in Apr 2026 — an FDA Class II recall (D-0508-2026) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride recalled?
- Per the FDA enforcement record, the reason for recall D-0508-2026 was: cGMP deviations.
- Is a recalled fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot 020226202150202, Exp Date 05/05/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0508-2026.