CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Semaglutide, For Rx compounding use only recalled
Harbin Jixianglong Biotech is recalling Semaglutide, For Rx compounding use only, distributed nationwide in the US. The recall was initiated on 13 Feb 2026 and the FDA has classified it as Class II.
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-0380-2026
- FDA event ID
- 98438
- Recalling firm
- Harbin Jixianglong Biotech, Haerbin, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Feb 2026
- FDA classified
- 2 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 13 Feb 2026 | Recall initiated by company | |
| 2 Mar 2026 | Classified by FDA | +17 days |
| 11 Mar 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Product as listed by the FDA
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Which lots are affected?
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98438| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Semaglutide, For Rx compounding use only recalled | Harbin Jixianglong Biotech | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Harbin Jixianglong Biotech
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Semaglutide, For Rx compounding use only recalled | Harbin Jixianglong Biotech | Manufacturing (CGMP) Deviations | Nationwide |