FDA Recall of fentaNYL Citrate Injectable Solution by Wells Pharma
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Wells Pharma of Houston LLC is voluntarily recalling 150 syringes of fentaNYL Citrate Injectable Solution due to cGMP deviations, affecting products distributed nationwide in the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Wells Pharma of Houston LLC is recalling their fentaNYL Citrate Injectable Solution due to cGMP deviations, as announced in a voluntary firm-initiated recall.
Which Products Are Affected
The affected product is fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), manufactured by Wells Pharma of Houston, with NDC 73702-203-65. The recall involves 150 syringes from Lot 022326203650432, with an expiration date of 06/25/2026. This recall is for products distributed nationwide in the United States.
What You Should Do
Consumers should stop using the affected product immediately and contact Wells Pharma of Houston LLC for further instructions. For returns or refunds, reach out to the firm at their address: 9265 Kirby Dr, Houston, TX 77054-2520, as initially notified via letter.
Why This Matters
This recall highlights potential quality issues in pharmaceutical manufacturing that could affect drug safety and efficacy for users. It is classified as a Class II recall, indicating a situation where use may cause temporary or reversible health consequences.
Source
This information is from the FDA recall notice, recall number D-0506-2026. Attribution: FDA (U.S. Food and Drug Administration).
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,263 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.