The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0566-2022·Announced 2022-02-23

Alprazolam Tablets USP 1.0 mg Recalled for cGMP Deviations

ANI Pharmaceuticals has recalled Alprazolam Tablets USP 1.0 mg distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 173,499 bottles across multiple lot numbers.

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: The FDA classified this as Class II. The recall is voluntary and based on manufacturing practice deviations rather than reported illness or injury. No illnesses or injuries are mentioned in the source text, so this falls under a moderate precautionary recall category.

Plain-English summary

ANI Pharmaceuticals, Inc. is recalling Alprazolam Tablets, USP 1.0 mg packaged in 100-count, 500-count, and 1000-count bottles. The affected product was distributed by Par Pharmaceutical to locations nationwide within the United States.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. This is a voluntary recall initiated by the firm. A total of 173,499 bottles are affected across multiple lot numbers with expiration dates ranging from February 2022 to June 2022.

The affected lot numbers are: - 100-count bottles (NDC 67253-902-10): Lots 19B081A (Exp. 02/2022), 19E088A (Exp. 05/2022), 19E089A (Exp. 05/2022) - 500-count bottles (NDC 67253-902-50): Lots 19A102B (Exp. 02/2022), 19D067B (Exp. 04/2022), 19D068B (Exp. 04/2022), 19D070C (Exp. 05/2022) - 1000-count bottles (NDC 67253-902-11): Lots 19F045C (Exp. 06/2022), 19F046C (Exp. 06/2022), 19B082C (Exp. 03/2022), 19B083C (Exp. 03/2022), 19D069C (Exp. 05/2022)

Consumers with affected product should contact their healthcare provider or pharmacist for guidance. This is a prescription medication; healthcare providers should verify whether their patients received affected batches.

The recalled product

Product
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Manufacturer
ANI Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
173,499

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 (17)

  • Lot #: a) 19B081A
  • Exp. Date 02/2022
  • 19E088A
  • 19E089A
  • Exp. Date 05/2022 b) 19A102B
  • 19D067B
  • 19D068B
  • Exp. Date 04/2022
  • 19D070C
  • Exp. Date 05/2022. c) 19F045C
  • 19F046C
  • Exp. Date 06/2022
  • 19B082C
  • 19B083C
  • Exp. Date 03/2022
  • 19D069C
  • Exp. Date 05/2022.

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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