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Class II: temporary or reversible health riskOngoing

Wells Pharma of Houston fentaNYL Citrate Injectable Solution Recall

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25…

Wells Pharma of Houston LLC · Houston, TX

Risk level
Class II
Reported by FDA
May 6, 2026
Recall ID
D-0505-2026
Check your lot numberHow we source this data

Summary

Wells Pharma of Houston recalled fentaNYL Citrate Injectable Solution starting Apr 1, 2026. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0505-2026 on May 6, 2026. Reason: cGMP deviations. Status: Ongoing.

Why it was recalled

cGMP deviations.

Product description

fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.

Lot numbers, UPCs & expiration codes

Lot 011226204250063, Exp Date 05/14/2026

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-0505-2026
Classification
Class II
Status
Ongoing
Recall initiated
Apr 1, 2026
FDA report date
May 6, 2026
Quantity
50 syringes
Recall type
Voluntary: Firm initiated
Recalling firm
Wells Pharma of Houston LLC

Original FDA data

Every field from FDA enforcement report D-0505-2026, 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
Lot 011226204250063, Exp Date 05/14/2026
Postal code
77054-2520
Report date
May 6, 2026
Product type
Drugs
Recall number
D-0505-2026
Classification
Class II
Recalling firm
Wells Pharma of Houston LLC
Product quantity
50 syringes
Reason for recall
cGMP deviations.
Voluntary / mandated
Voluntary: Firm initiated
Product description
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
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-0505-2026, published May 6, 2026. View the source record (openFDA) · FDA enforcement reports

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

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