Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported May 6, 2026
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
cGMP deviations.
The recall
Wells Pharma of Houston LLC issued this moderate-severity FDA Drug recall — cGMP deviations..
- Moderate
- severity level
- Class II
- classification
- May 6, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0503-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0503-2026) was formally reported on May 6, 2026, with the manufacturer initiating the action on April 1, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wells Pharma of Houston LLC is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 4,030 IV Bags.
The documented reason for this recall is: cGMP deviations. Distribution data in the federal record shows the product reached: U.S. Nationwide.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug and 5 from Wells Pharma of Houston LLC — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Household Products recalls over time
Where this recall sits in its category — 2,542 household products recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
4,030 IV Bags
Related Recalls
6
5 from same agency
Product description
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
Reason for recall
cGMP deviations.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0503-2026 |
| Date reported | May 6, 2026 |
| Date initiated | April 1, 2026 |
| Recalling firm | Wells Pharma of Houston LLC |
| Firm location | Houston, TX |
| Affected scope | 4,030 IV Bags |
| Distribution | U.S. Nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.. Recalled by Wells Pharma of Houston LLC. Units affected: 4,030 IV Bags.
Why was this product recalled? ▼
cGMP deviations.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 6, 2026. Severity: Moderate. Recall number: D-0503-2026.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0503-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Wells Pharma of Houston LLC · 2026-05-06
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Compare this recall with Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed … →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Drug, reported May 6, 2026.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).