CLASS II ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report
fentaNYL Citrate Injectable Solution in 9% Sodium Chloride recalled
Wells Pharma of Houston is recalling fentaNYL Citrate Injectable Solution in 9% Sodium Chloride, 50 mcg/(10 mcg per mL), wells, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0508-2026
- FDA event ID
- 98694
- Recalling firm
- Wells Pharma of Houston, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +27 days |
| 6 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations.
Product as listed by the FDA
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is fentaNYL Citrate Injectable Solution in 9% Sodium Chloride, 50 mcg/(10 mcg per mL), wells recalled?
Yes. Wells Pharma of Houston recalled fentaNYL Citrate Injectable Solution in 9% Sodium Chloride, 50 mcg/(10 mcg per mL), wells on 1 Apr 2026. The recall is Class II and its status is Ongoing. Recall number D-0508-2026.
Why was it recalled?
cGMP deviations.
Which lots are affected?
Lot 020226202150202, Exp Date 05/05/2026.
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Wells Pharma of Houston
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate injectable Solution in 9% Sodium Chloride recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution in 9% Sodium Chloride recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
Other Fentanyl citrate injectable recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate injectable Solution in 9% Sodium Chloride recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution in 9% Sodium Chloride recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |