FDA recall, , Moderate risk
Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions
Injectable solutions of phenylephrine, fentanyl, and ketamine have cGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Wells Pharma of Houston LLC, based in Houston, Texas, recalled injectable solutions of phenylephrine, fentanyl, and ketamine due to cGMP deviations. The recall began April 1, 2026, and was added to the FDA's Enforcement Report on April 28, 2026, with nationwide distribution in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
- Strength
- 1000 mcg
- NDC
- 73702-203-65
- Lot code
- 022326203650432
- Strength
- 50 mcg
- NDC
- 73702-202-15
- Lot code
- 020226202150202
Ketamine Hydrochloride Injectable Solution
- Strength
- 50 mg/mL
- NDC
- 73702-302-31
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (
- Strength
- 2500 mcg
- UPC
- 02182202030398
fentaNYL Citrate Injectable Solution, Narcotic, Cii
- Strength
- 1000 mcg
- NDC
- 73702-202-02
- Strength
- 1250 mcg
- NDC
- 73702-204-25
- Lot code
- 011226204250063
Some entries omit identifying details. Check the notice to confirm which units are affected.
Phenylephrine Hydrochloride Injectable Solution
- Strength
- 40 mg
- NDC
- 73702-122-03
Recall details
- Company began the recall
- Sold in
U.S. Nationwide.
- Company
- Wells Pharma of Houston LLCHouston, Texas
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98694
- Recall numbers
- D-0502-2026 to D-0508-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
