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Semaglutide Bulk API
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DRUG RECALLMODERATE

Semaglutide Bulk API

Harbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.

What to do

Do not use this semaglutide for compounding. Return the product to your supplier or dispose of it according to your pharmacy's procedures. Contact Harbin Jixianglong Biotech Co., Ltd. for further instructions.

Recalled
Listed
Updated
Recall No.
D-0380-2026
Agency
FDA
Firm
Harbin Jixianglong Biotech Co., Ltd.
Recall ID
98438
Status
ONGOING

Why it was recalled

Harbin Jixianglong Biotech Co., Ltd. is recalling semaglutide bulk drug substance intended for prescription compounding due to CGMP deviations, specifically failure to complete process validation and bacterial endotoxin method validation before distribution. The recall affects multiple package sizes of the active pharmaceutical ingredient.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Semaglutide, For Rx compounding use only

UPCRecall #
20250911D-0380-2026
20250711D-0379-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification