Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054,
Summary
The FDA issued a Class II for Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL by Wells Pharma of Houston LLC. Reason: cGMP deviations..
Details
Source
Drug Recall
External ID
D-0507-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
Product Description
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Lot/Code Info: 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.
Quantity Affected: 4975 syringes
Reason for Recall
cGMP deviations.
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-01
Company
Houston, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Wells Pharma of Houston LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wells Pharma of Houston LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wells Pharma of Houston LLC have FDA actions?
Wells Pharma of Houston LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0507-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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