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Class II: temporary or reversible health riskOngoing

Wells Pharma of Houston fentaNYL Citrate injectable Solution in 0 Recall

fentaNYL Citrate injectable Solution in 0

Wells Pharma of Houston LLC · Houston, TX

Risk level
Class II
Reported by FDA
May 6, 2026
Recall ID
D-0504-2026
Check your lot numberHow we source this data

Summary

Wells Pharma of Houston recalled fentaNYL Citrate injectable Solution in 0 starting Apr 1, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0504-2026 on May 6, 2026. Reason: cGMP deviations. Status: Ongoing.

Why it was recalled

cGMP deviations.

Product description

fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.

Lot numbers, UPCs & expiration codes

120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.

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-0504-2026
Classification
Class II
Status
Ongoing
Recall initiated
Apr 1, 2026
FDA report date
May 6, 2026
Quantity
2940 IV Bags
Recall type
Voluntary: Firm initiated
Recalling firm
Wells Pharma of Houston LLC

Original FDA data

Every field from FDA enforcement report D-0504-2026, 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
120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/06/2026, 02182202030398, Exp Date 06/20/2026.
Postal code
77054-2520
Report date
May 6, 2026
Product type
Drugs
Recall number
D-0504-2026
Classification
Class II
Recalling firm
Wells Pharma of Houston LLC
Product quantity
2940 IV Bags
Reason for recall
cGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
Product description
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Distribution pattern
U.S. Nationwide.
Recall initiation date
Apr 1, 2026
Initial firm notification
Letter
Center classification date
Apr 28, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0504-2026, published May 6, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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