Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC… recall
FDA recall D-0380-2026 · initiated Feb 13, 2026
Harbin Jixianglong Biotech Co., Ltd. recalled Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… in Feb 2026 — an FDA Class II recall (D-0380-2026) because CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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.
- Recalling company
- Harbin Jixianglong Biotech Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Feb 13, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… recalled?
- Harbin Jixianglong Biotech Co., Ltd. recalled Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… in Feb 2026 — an FDA Class II recall (D-0380-2026) because CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… recalled?
- Per the FDA enforcement record, the reason for recall D-0380-2026 was: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Is a recalled Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;… are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0380-2026.