FDA Drug recall · Reported February 23, 2022
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Revive Rx LLC dba Revive Rx Pharmacy recalled HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV… - a critical-severity action.
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV… was recalled by Revive Rx LLC dba Revive Rx Pharmacy in February 23, 2022. Reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus.. Check the official notice for the remedy. Verify recall #D-0648-2022 with the FDA Drug before acting.
The recall
Revive Rx LLC dba Revive Rx Pharmacy issued this critical-severity FDA Drug recall-Non-sterility; bacterial contamination identified as Paenibacillus lautus..
- Critical
- severity level
- Class I
- classification
- February 23, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0648-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 515 outdoor & sports recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Reason for recall
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0648-2022 |
| Date reported | February 23, 2022 |
| Date initiated | February 11, 2022 |
| Recalling firm | Revive Rx LLC dba Revive Rx Pharmacy |
| Firm location | Houston, TX |
| Affected scope | 115 vials |
| Distribution | Nationwide in the US. |
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-0648-2022) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Outdoor & Sports · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026