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FDAClass II · Drug · Recalled May 6, 2026
Ketamine Hydrochloride Injectable Solution recall — Wells Pharma of Houston LLC
Hazard: cGMP deviations.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0507-2026
- Brand
- Wells Pharma of Houston
- Classification
- Class II
- Units affected
- 4975 syringes
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Affected products
Companies & origin
- Recalling firm location
- Houston, TX, United States
- Firm address
- 9265 Kirby Dr, 77054-2520
Identifying details (verbatim from the notice)
- Product codes / lots
- 120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026.
- Distribution
- U.S. Nationwide.
- Firm notified the public via
- Letter
- FDA event ID
- 98694
- Recall initiated
- April 1, 2026
- FDA classified
- April 28, 2026
- FDA report date
- May 6, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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