Xanax XR
Failed Dissolution Specifications
Yes — there is an active recall. 4 ongoing FDA recalls mention Alprazolam (33 total). Check the affected lots below.
Most common reason: Cross-contamination (13 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alprazolam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Dissolution Specifications
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
Failed Dissolution Specifications: low out of specification results for dissolution.
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
CGMP deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
Presence of Foreign Substance
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
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