The Recall Desk
ModerateFDA (Drugs)·D-0564-2022·Announced 2022-02-23

Alprazolam Tablets USP 0.25 mg Recalled for cGMP Deviations

ANI Pharmaceuticals is recalling Alprazolam Tablets USP 0.25 mg nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects multiple lot numbers of 100-count, 500-count, and 1000-count bottles distributed across 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 recall initiated voluntarily by the manufacturer for cGMP deviations. The source text does not report any illnesses, injuries, or hospitalization related to these tablets. cGMP deviations represent a quality/manufacturing control issue rather than confirmed product contamination or an active hazard, placing this in the Moderate category.

Plain-English summary

ANI Pharmaceuticals, Inc. is voluntarily recalling Alprazolam Tablets, USP 0.25 mg, distributed by Par Pharmaceutical. The recall affects three packaging sizes: 100-count bottles (NDC 67253-900-10), 500-count bottles (NDC 67253-900-50), and 1000-count bottles (NDC 67253-900-11). A total of 73,920 bottles were distributed nationwide within the United States.

The recall was initiated on February 15, 2022, due to current Good Manufacturing Practice (cGMP) deviations identified by the manufacturer. The affected lot numbers are: 19C003A (exp. 03/2022), 19G002A (exp. 07/2022), 19C004B (exp. 03/2022), and 19C048C (exp. 03/2022).

Patients taking this medication should consult their healthcare provider or pharmacist before discontinuing use. Healthcare providers and patients who have this medication should contact ANI Pharmaceuticals or their pharmacist for further instructions. The recall was terminated on October 25, 2022.

The recalled product

Product
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Benzodiazepine / Anxiety Medication
Hazard
Affected units
73,920

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 (6)

  • Lot #: a) 19C003A
  • Exp. Date 03/2022
  • 19G002A
  • exp. date 07/2022
  • b) 19C004B
  • c) 19C048C

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 →

Related recalls

Same manufacturer · ANI Pharmaceuticals, Inc.

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Same hazard · cGMP deviation

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