Lower riskDrug recall · FDA · Published May 11, 2023
Revive Rx recalls Tirzepatide 10mg/0.5mL vial: Sub-potent drug risk
Revive Rx recalls specific Tirzepatide 10mg/0.5mL vials due to potential sub-potent drug levels. Affected units were compounded by Revive Rx Pharmacy in Houston, TX. Consumers should contact the manufacturer for details.
📍Recalling firmRevive Rx LLC dba Revive Rx Pharmacy3831 Golf Dr Ste A · Houston, TX 77018-5218
✎ GovInfoNow plain-language explainer
Revive Rx is recalling Tirzepatide 10 mg/0.5 mL vials that may contain less active drug than intended. This could lead to ineffective treatment for diabetes or obesity. The recall is for compounded products sold with specific lot and expiration dates. Read more at govinfonow.com/recall/33492-revive-rx-recalls-tirzepatide-10mg-0-5ml-vial-sub-potent.
“Revive Rx recalls Tirzepatide 10mg/0.5mL vial: Sub-potent drug risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33492-revive-rx-recalls-tirzepatide-10mg-0-5ml-vial-sub-potent. Based on FDA recall #D-0771-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0771-2023%22&limit=1).
The FDA announced on May 11, 2023, that Revive Rx LLC dba Revive Rx Pharmacy is recalling Tirzepatide 10 mg/0.5 mL Sterile Solution due to sub-potent drug risks. The voluntary Class II recall affects 45 vials distributed nationwide.
How to tell if you have it
Brand: Revive Rx
Product: Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive
NDC: 99000-9278-64
Lot: 1643397
BUD: 10/16/2023
Quantity: 45 Vials
The hazard
The recalled product is a sub-potent drug. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Revive Rx LLC dba Revive Rx Pharmacy has two other recalls on record since February 11, 2022. On April 20, 2024, the pharmacy recalled a Tirzepatide vial due to a testosterone mix-up hazard. On February 11, 2022, Revive Rx issued an HCG Injection recall for bacterial contamination risk. Other recent recalls of similar products include New Life Pharma Tirzepatide Inj 15mg Vial Recall (February 26, 2026), New Life Pharma Tirzepatide 10mg Vial Recall (February 26, 2026), and ProRx recalls Tirz (October 15, 2025).
How to tell if you have this one
Check for the vial labeled 'Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only' compounded by Revive Rx Pharmacy. The lot number 1643397 and expiration date 10/16/2023 are specific identifiers.
Brand
Revive Rx
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Vial Details
Look for the lot number 1643397 and expiration date 10/16/2023 on the vial label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0771-2023 (May 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0771-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.