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Safety & recalls

FDA lists ongoing Houston Rx recall for two injectable products; recall began September 25

FDA Event 99990 lists 64 tirzepatide/niacinamide vials and seven sermorelin vials, with different manufacturing-control concerns. The recall began September 25 and was classified October 13, not newly initiated October 15.

Published October 15, 2026 · Primary-source editorial check October 15, 2026

FDA's Enforcement Report lists an ongoing voluntary recall by Houston Rx LLC covering two prescription injectable products. Event 99990 says the firm initiated the recall on September 25, 2026 and the agency classified it on October 13. This brief checks that active record on October 15; it does not describe a new recall initiated today.

The tirzepatide/niacinamide entry is recall number D-0040-2027. FDA lists 64 vials and gives the reason as lack of assurance of sterility. The code information identifies lot TZN-080326-20/2-2 and a beyond-use date of December 1, 2026. Those identifiers define the listed product scope, rather than every tirzepatide product or every product from the firm.

The sermorelin entry is recall number D-0041-2027. FDA lists seven vials and gives a different reason: lack of process control. Its code information identifies lot SER-081726-1-10 and a beyond-use date of October 1, 2026. The report describes both products as injectable; no administration or dosing instructions are provided here.

Both entries are classified as Class II, and the event shows nationwide distribution in the United States. The report says the firm initiated the action voluntarily and used two or more notification methods from the agency's listed options. It does not identify an individual patient's product as affected without matching the product and lot information.

The event page says no press release was issued for this recall and displays no product update history. The cited reasons concern manufacturing and quality controls. They are not, by themselves, proof that an adverse event occurred in a particular patient, nor evidence that all products outside these entries are safe or FDA approved.

Anyone checking a product should use the exact FDA record and ask the dispensing pharmacy or treating clinician whether the listed product and lot apply and what recall-specific steps are appropriate. This is a dated safety notice, not a provider endorsement, treatment recommendation or buying guide. The record's ongoing status and original initiation date should stay together when the notice is shared.

Information, not medical advice. No independent medical review or treatment endorsement.