The Recall Desk
HighFDA (Drugs)·D-0459-2023·Announced 2023-03-22

Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk

Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a controlled pharmaceutical product with manufacturing deviations creating a potential cross-contamination risk. Although no illnesses or injuries are reported in the source material, the hazard is serious enough to warrant a Class II designation and affects a medication where contamination poses a potential risk of harm.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling multiple lots of Alprazolam Tablets, USP, 0.5mg (Controlled Substance IV), distributed nationwide. The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations that created a potential risk of cross-contamination. The product is manufactured by Centaur Pharmaceuticals PVT. LTD. in Pune, India, and distributed in 100-count, 500-count, and 1,000-count bottles.

Multiple lot numbers are affected, with expiration dates ranging from March 2023 through November 2024. The affected lots are distributed across all three package sizes. Consumers and healthcare providers should check their inventory against the published list of affected lot numbers.

Consumers should immediately stop use of any product matching the affected lot numbers. Contact your pharmacy or healthcare provider with questions or to report any adverse effects.

The recalled product

Product
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Benzodiazepine
Hazard
  • cross-contamination
  • manufacturing-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 (20)

  • Lot # a) 5210673
  • exp. date 3/31/2023
  • 5210901
  • exp. date 5/31/2023
  • 5211461
  • exp. date 9/30/2024
  • 5220291
  • exp. date 2/28/2025
  • 5220559
  • exp. date 5/31/2025
  • b) 5210650
  • 5210651
  • exp. date 3/31/2023 5210652
  • exp. date 3/31/2023 5210653
  • exp. date 3/31/2023 5210674
  • exp. date 3/31/2023 5210732
  • exp. date 3/31/2023 5210733
  • exp. date 4/30/2023 5210753
  • exp. date 4/30/2023 5210902
  • exp. date 5/31/2023 5210903

Distribution

Distributed nationwide across the United States.

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