FDA Recall D-0380-2026

Harbin Jixianglong Biotech Co., Ltd. · Haerbin, N/A

Class II Ongoing 90 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.

Quantity: N/A

Reason for recall

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Recall record

Recall number: D-0380-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide within the United States
Recall initiated: 2026-02-13
Classified by FDA Center: 2026-03-02
FDA published: 2026-03-11
Recalling firm: Harbin Jixianglong Biotech Co., Ltd.
Firm location: Haerbin, N/A, China

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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