Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Is Lactulose recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Lactulose (9 total). Check the affected lots below.
Most common reason: Microbial contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lactulose. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lactulose recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Lactulose Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Lactulose Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Lactulose Solution
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk
Lactulose Solution
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
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