The Recall Desk
ModerateFDA (Drugs)·D-0567-2022·Announced 2022-02-23

Alprazolam Tablets 2.0 mg Recalled for cGMP Deviations

ANI Pharmaceuticals is recalling Alprazolam Tablets, USP 2.0 mg nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects approximately 70,788 bottles distributed throughout the United States.

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: This is an FDA Class II voluntary recall with no reported illnesses or injuries. The hazard (cGMP deviations) is a manufacturing/process concern rather than a specific product defect with direct harm potential, making it a precautionary recall typical of Moderate severity.

Plain-English summary

ANI Pharmaceuticals, Inc. is recalling Alprazolam Tablets, USP 2.0 mg packaged in 100-count bottles (NDC 67253-903-10) and 500-count bottles (NDC 67253-903-50), distributed nationwide within the United States. The recall was initiated due to cGMP deviations identified in the manufacturing process.

The affected product includes the following lot numbers and expiration dates: - 100-count bottles: Lot #19C002A (Exp. 03/2022), Lot #19E012A (Exp. 05/2022), Lot #19E013A (Exp. 05/2022) - 500-count bottles: Lot #19C100B (Exp. 04/2022), Lot #19E001B (Exp. 05/2022), Lot #19E002B (Exp. 05/2022)

Approximately 70,788 bottles have been distributed. The recall is voluntary and was initiated by the firm on February 15, 2022, and terminated on October 25, 2022. Consumers who have this medication should consult with their healthcare provider or pharmacist regarding their prescription before taking any action.

The recalled product

Product
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Benzodiazepine
Hazard
  • cgmp-deviation
  • manufacturing-defect

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 (9)

  • Lot #: a) 19C002A
  • Exp. Date 03/2022
  • 19E012A
  • 19E013A
  • Exp. Date 05/2022. b) 19C100B
  • Exp. Date 04/2022
  • 19E001B
  • 19E002B
  • Exp. Date 05/2022.

Distribution

Distributed nationwide across the United States.

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