The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0565-2022·Announced 2022-02-23

Alprazolam Tablets 0.5 mg Recalled Due to cGMP Deviations

ANI Pharmaceuticals is voluntarily recalling Alprazolam Tablets USP 0.5 mg in multiple package sizes nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 205,662 bottles distributed across the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 recall initiated voluntarily by the manufacturer for cGMP deviations. The source text does not report any illnesses, injuries, or deaths associated with the product. The recall is precautionary in nature based on manufacturing process deviations rather than demonstrated harm.

Plain-English summary

ANI Pharmaceuticals, Inc. is voluntarily recalling Alprazolam Tablets, USP 0.5 mg in three package sizes: 100-count bottles (NDC 67253-901-10), 500-count bottles (NDC 67253-901-50), and 1000-count bottles (NDC 67253-901-11). All packages are marked "Rx only" and were distributed by Par Pharmaceutical of Chestnut Ridge, New York.

The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations identified in the manufacturing process. Approximately 205,662 bottles have been distributed nationwide within the United States. Specific lot numbers and expiration dates affected by this recall are detailed in the recall notice.

Consumers and healthcare providers with affected bottles should stop use and consult with a healthcare professional or pharmacist before discontinuing this medication. Patients should not stop taking alprazolam without medical guidance due to potential withdrawal effects. The affected lot numbers and expiration dates can be verified through the FDA recall notice or by contacting ANI Pharmaceuticals.

The recalled product

Product
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Prescription Benzodiazepine
Hazard
Affected units
205,662

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 (20)

  • Lot #: a) 19B029A
  • Exp. Date 02/2022
  • 19D021A
  • Exp. Date 04/2022. b) 19A087B
  • 19A088B
  • 19A089B
  • 19A090B
  • 19A086B
  • 19A091B
  • 19B019B
  • Exp. Date 02/2022. c) 19B020C
  • 19B021C
  • 19B027C
  • 19B028C
  • 19E056C
  • 19E057C
  • Exp. Date 05/2022
  • 19E059C
  • Exp. Date 06/2022 19G072C
  • Exp. Date 07/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by ANI Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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