The Recall Desk
HighFDA (Drugs)·D-0506-2023·Announced 2023-04-12

Alprazolam 1mg tablets recalled for manufacturing contamination risk

Preferred Pharmaceuticals is recalling Alprazolam 1mg tablets due to manufacturing deviations that created a potential cross-contamination risk. Affected lots expire August 2024.

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: FDA Class II recall for a pharmaceutical product with manufacturing deviations creating cross-contamination risk. While no illnesses or specific contaminants have been reported, this constitutes a risk-of-harm product with documented integrity defects.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Alprazolam tablets, USP 1mg, in 30-count and 60-count bottles due to manufacturing deviations identified at the supplier, Breckenridge Pharmaceuticals, Inc. These deviations created a potential risk of cross-contamination.

Affected lot numbers are H3122D, A1123R, L0522E, J2622H, I1622F, and H2422E, all expiring August 31, 2024. The recalled product was distributed nationwide in the United States. No illnesses or injuries have been reported.

Patients taking affected tablets should consult their healthcare provider or pharmacist before taking any action. Do not abruptly stop taking Alprazolam without medical guidance, as this can be unsafe. Affected medication should be returned to the dispensing pharmacy.

The recalled product

Product
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Benzodiazepine
Hazard

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 (8)

  • Lot # a) H3122D
  • Exp. Date:8/31/2024
  • b) Lot #A1123R
  • L0522E
  • J2622H
  • I1622F
  • H2422E
  • Exp. Date:8/31/2024.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Preferred 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 3 products in this recall →

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Same manufacturer · Preferred Pharmaceuticals, Inc.

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