Why it was recalled
cGMP deviations.
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.
Lot numbers, UPCs & expiration codes
120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0503-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 1, 2026
- FDA report date
- May 6, 2026
- Quantity
- 4,030 IV Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wells Pharma of Houston LLC
Original FDA data
Every field from FDA enforcement report D-0503-2026, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 98694
- Address
- 9265 Kirby Dr
- Code information
- 120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026
- Postal code
- 77054-2520
- Report date
- May 6, 2026
- Product type
- Drugs
- Recall number
- D-0503-2026
- Classification
- Class II
- Recalling firm
- Wells Pharma of Houston LLC
- Product quantity
- 4,030 IV Bags
- Reason for recall
- cGMP deviations.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Apr 1, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2026