Lexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
Lexia LLC is recalling Broadway Joe's Pain Cream in Colorado due to CGMP deviations and potential raw material contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source cites CGMP deviations and potential contamination without reporting specific illnesses or injuries, aligning with a moderate severity rating.
Plain-English summary
Lexia LLC is voluntarily recalling 2,400 two-ounce jars of Broadway Joe's Pain Cream. The product contains Histamine Dihydrochloride 0.025%, 1500mg CBD Isolate, and 1000mg Hempseed oil. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and the potential contamination of raw material.
The affected product was distributed in the state of Colorado. The recall includes specific lots with expiration dates ranging from January 7, 2027, to January 17, 2027. The product is identified by NDC 83088-8120-5 and UPC 8 50041 64003 7.
Consumers who have purchased this product should stop using it and contact Lexia LLC for further instructions or a refund.
The recalled product
- Product
- Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
- Manufacturer
- Lexia LLC
- Category
- Drug — Topical Pain Cream
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot #: T1110
- Exp: 1/7/2027
- T1111
- Exp: 1/9/2027
- T1112
- Exp: 1/16/2027
- T1113
- Exp: 1/17/2027
- T1114
Distribution
Distributed in 1 state:
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