CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj. recalled
Revive Rx is recalling HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV, distributed nationwide in the US. The recall was initiated on 11 Feb 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0648-2022
- FDA event ID
- 89591
- Recalling firm
- Revive Rx, Houston, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Feb 2022
- FDA classified
- 8 Mar 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Feb 2022 | Recall initiated by company | |
| 23 Feb 2022 | Published in enforcement report | +12 days |
| 8 Mar 2022 | Classified by FDA | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the US.
Questions about this recall
Is HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV recalled?
Yes. Revive Rx recalled HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV on 11 Feb 2022. The recall is Class I and its status is Terminated. Recall number D-0648-2022.
Why was it recalled?
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Which lots are affected?
Lot: 631359 BUD: 05/01/2022
Where was it sold?
Nationwide in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Revive Rx
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tirzepatide 10 mg/ Sterile Solution Multi-dose vial recalled | Revive Rx | Sterility | Nationwide |
| Drug | CLASS II | Tirzepatide 10 mg/ Sterile Solution- Vial recalled by Revive Rx | Revive Rx | Sterility | Nationwide |