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
Product description
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.
Lot numbers, UPCs & expiration codes
Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0380-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 13, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Harbin Jixianglong Biotech Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0380-2026, exactly as published.
Show all FDA fields
- City
- Haerbin
- Status
- Ongoing
- Country
- China
- Event ID
- 98438
- Address
- North Of Baoan Road, East Of Changqing Street
- Address (line 2)
- Hulan District
- Code information
- Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0380-2026
- Classification
- Class II
- Recalling firm
- Harbin Jixianglong Biotech Co., Ltd.
- Reason for recall
- CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 13, 2026
- Initial firm notification
- Center classification date
- Mar 2, 2026