Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 o
Summary
The FDA issued a Class II for Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB by Lexia LLC. Reason: CGMP Deviations: Potential contamination of raw material.
Details
Source
Drug Recall
External ID
D-0829-2026
Action Date
2026-09-09
Status
Ongoing
Category
drug
Product Description
Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
Lot/Code Info: Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
Quantity Affected: 1,200 4 oz-Jar
Reason for Recall
CGMP Deviations: Potential contamination of raw material
Distribution
Distributed in the state of Colorado (US).
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-21
Company
Franklin, TN
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 53 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Lexia LLC has 2 FDA actions in our database, including 2 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 (Lexia LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lexia LLC have FDA actions?
Lexia LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0829-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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