Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported June 5, 2024
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Revive Rx LLC dba Revive Rx Pharmacy recalled Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compo… - a critical-severity action.
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compo… was recalled by Revive Rx LLC dba Revive Rx Pharmacy in June 5, 2024. Reason: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate. Check the official notice for the remedy. Verify recall #D-0511-2024 with the FDA Drug before acting.
The recall
Revive Rx LLC dba Revive Rx Pharmacy issued this critical-severity FDA Drug recall-Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate.
- Critical
- severity level
- Class I
- classification
- June 5, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0511-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0511-2024) was formally reported on June 5, 2024, with the manufacturer initiating the action on April 20, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Revive Rx LLC dba Revive Rx Pharmacy is listed as the recalling firm, operating out of Houston, TX. Federal records list the affected scope as 751 vials.
The documented reason for this recall is: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Outdoor & Sports recalls over time
Where this recall sits in its category - 510 outdoor & sports recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
751 vials
Related Recalls
6
0 from same agency
Product description
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
Reason for recall
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0511-2024 |
| Date reported | June 5, 2024 |
| Date initiated | April 20, 2024 |
| Recalling firm | Revive Rx LLC dba Revive Rx Pharmacy |
| Firm location | Houston, TX |
| Affected scope | 751 vials |
| Distribution | USA Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0511-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64. Recalled by Revive Rx LLC dba Revive Rx Pharmacy. Units affected: 751 vials.
Why was this product recalled? ▼
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2024. Severity: Critical. Recall number: D-0511-2024.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0511-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Shenzhen Fuxiangyue Technology Co., Ltd., dba Arrogantf, of China · 2026-06-18
CPSC Moderate
Houoto 642-2150V Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards…
Foshan Nanhai District Haichen Tengfei Hardware Factory, of China · 2026-06-11
CPSC Moderate
Joyin Recalls Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement; Violate Federal Dive Sticks Ban
· 2026-06-11
CPSC Moderate
Bicycle Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury; Violates Mandatory Standard for Bicyc…
Dongguanshizhouhedianzishangwuyouxiangongsi (Dongguan Zhouhe E-commerce Co., Ltd.) dba Gudook Outdoor Sports, of China · 2026-06-04
Compare this recall with Topyond Pool Drain Ports with Covers Recalled Due to Risk o… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 5, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.