The Recall Desk
ModerateFDA (Drugs)·D-0651-2022·Announced 2022-03-16

Alprazolam 2 mg tablets recalled due to potential cross-contamination

Direct Rx is recalling Alprazolam C-IV 2 mg tablets (Lot #07NO1901, expiration 5/31/22) distributed in Florida, Georgia, and Louisiana due to potential cross-contamination identified at the contract manufacturer Ultra Tab Laboratories Inc.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this recall as Class II. The source text does not report any actual illnesses, injuries, or confirmed cross-contamination—only the potential for it due to CGMP deviations. This meets the rubric criterion for a Moderate severity recall: manufacturing/precautionary issue without reported adverse outcomes.

Plain-English summary

Direct Rx is recalling Alprazolam C-IV 2 mg tablets in 60-count bottles (NDC 72189-0058-60, Lot #07NO1901, expiration date 5/31/22). Eight bottles were distributed to Florida, Georgia, and Louisiana.

The recall was initiated due to potential cross-contamination at Ultra Tab Laboratories Inc., the contract manufacturer. The contamination constitutes a deviation from Current Good Manufacturing Practice (CGMP) standards.

Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Consumers in possession of the recalled product should not use it and should return it to their pharmacy or consult their healthcare provider for replacement medication.

The recalled product

Product
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60
Manufacturer
Direct Rx
Hazard
  • cross-contamination
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #: 07NO1901 Exp. 5/31/22

Distribution

Distributed in 3 states:

  • FL
  • GA
  • LA