← FDA ENFORCEMENT
D-0508-2026Class II
Wells Pharma of Houston LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Wells Pharma of Houston LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-06
Distribution
U.S. Nationwide.
Firm state
TX
Product quantity
50 syringes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations.
Product description
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Code / lot info
Lot 020226202150202, Exp Date 05/05/2026.
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See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →