Houston Rx LLC Recalls Tirzepatide/Niacinamide Vials Due to Sterility Concerns
Houston Rx LLC is recalling 64 vials of Tirzepatide/Niacinamide injection due to a lack of assurance of sterility. The product was distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Houston Rx LLC is recalling 64 vials of Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL. The recall was initiated because of a lack of assurance of sterility in the product. The affected lot number is TZN-080326-20/2-2, with a beyond use date of 12/01/2026.
The product was distributed nationwide in the USA. It is a prescription-only medication. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
- Manufacturer
- Houston Rx LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 64
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 (2)
- Lot# TZN-080326-20/2-2
- Beyond Use Date: 12/01/2026.
Distribution
Distributed nationwide across the United States.
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