FDA Warns China-Based Pharma Firm Over Relabeled GLP-1 Ingredients Shipped to US

The Food and Drug Administration (FDA) warned a Chinese pharmaceutical company in Harbin, China, after inspectors found quality-control failures involving relabeled semaglutide ingredients shipped to the United States.

Kelly McBride Ni

Published: 5/21/2026, 11:52:00 PM EDT

FDA Warns China-Based Pharma Firm Over Relabeled GLP-1 Ingredients Shipped to US — An obesity doctor and consultant showing various GLP-1 self-injectable devices at a clinic in a file photo. (Indranil Mukherjee/AFP via Getty Images)

According to the FDA’s warning letter to Harbin Jixianglong Biotech Co., Ltd., the company repackaged and relabeled active pharmaceutical ingredients sourced from outside suppliers, changed manufacturing and retest dates without supporting documentation, and failed to maintain adequate manufacturing, testing, and contamination controls for the GLP-1 drug ingredient.

Senator Tom Cotton (R-Ark.) commented on the case in a May 21 post on X, saying, “A Chinese pharmaceutical company relabeled drug ingredients from an unapproved source and changed manufacturing dates before shipping them to America.”

“We can’t keep depending on Chinese-linked pharmaceutical supply chains for our medicines,” he said.

The FDA said the company agreed during a February teleconference to voluntarily recall two semaglutide active pharmaceutical ingredient batches distributed in the U.S.

Semaglutide and tirzepatide are active pharmaceutical ingredients, the raw chemical components used to make GLP-1 medications prescribed for conditions such as Type 2 diabetes and weight loss.

These ingredients are typically incorporated into finished sterile injectable drugs with strict standards for contamination controls.

The warning letter said violations extended beyond relabeling practices and included manufacturing failures, such as incomplete process validation, inadequate cleaning controls, insufficient laboratory testing validation, and weaknesses in water system monitoring for materials intended for sterile injectable use.

Water Testing Failures

FDA inspectors said the company’s non-sterile drug ingredients were meant for sterile injectable drugs, but its water system was not properly checked for harmful microbes, also called “objectionable microorganisms.”

Objectionable microorganisms are bacteria or other microbes that can threaten drug quality, effectiveness, purity, and patient safety.

The warning letter also said there was no indication that the company tested for endotoxins—toxic substances produced by certain bacteria—during manufacturing.

It further noted that water used in production was not adequately sampled or tested, including water that was manually transported and stored for use in manufacturing processes.

The FDA requires drugmakers to continuously test and monitor water systems used in manufacturing to ensure they are free of harmful chemicals and microbes.

The company acknowledged that it had not fully assessed the risks of microbial contamination or implemented adequate controls for its water system, according to the FDA.

It also said it would add testing for E. coli, but the FDA said the response did not address all of the microbial monitoring requirements outlined in the warning letter.

Unknown Supplier, Repackaged and Relabeled

The FDA also raised concerns that Harbin falsely identified itself as the manufacturer of GLP-1 ingredients, when the materials were actually sourced from another company not approved under the FDA’s list of cleared facilities for these products.

In the warning letter, the agency said it was concerned the labeling “may have been an attempt to circumvent safeguards” and could “pose a risk to consumers of receiving substandard GLP-1 APIs.”

On Feb. 27, the FDA placed the company under an import alert, allowing officials to detain shipments without physical inspection, and removed the company from the GLP-1 clearance list used for reviewing incoming drug ingredients.

The FDA’s letter also said the company shipped tirzepatide batches to the U.S. before completing tests to prove that the drugs would remain effective until the listed expiration dates.

Harbin said it sometimes bought products from other suppliers to meet high U.S. demand, but the FDA said the company lacked proper procedures for these purchases and failed to explain what would happen to semaglutide batches already sold.

The warning letter applies to active pharmaceutical ingredients, not the finished prescription drugs sold directly to patients. However, semaglutide and tirzepatide are widely used in GLP-1 therapies and compounded medications.

Harbin was given 15 working days to respond with corrective actions and a remediation plan.