The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0505-2023·Announced 2023-04-12

Alprazolam 0.5mg Tablets Recalled Due to Potential Cross Contamination

Preferred Pharmaceuticals is recalling Alprazolam 0.5mg tablets nationwide due to CGMP manufacturing deviations at Breckenridge Pharmaceuticals that created a potential cross-contamination risk.

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 3/5 (High).

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 is an FDA Class II recall of a pharmaceutical product where manufacturing deviations created a potential cross-contamination risk. Although no illnesses or injuries have been reported, CGMP violations affecting medication integrity represent a credible risk-of-harm, meeting the rubric criterion for Score 3.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Alprazolam Tab, USP 0.5mg tablets distributed nationwide in the United States. The recall affects tablets packaged in 30-count, 60-count, and 90-count bottles.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations at the manufacturer, Breckenridge Pharmaceuticals, Inc. located in Boca Raton, Florida. These deviations created a potential risk of cross contamination of the product.

Patients currently taking this medication should contact their healthcare provider or pharmacist to determine if they have affected lot numbers and to obtain replacement medication. The FDA and the recalling firm are not aware of any reported illnesses or injuries related to this recall.

The recalled product

Product
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c) 90-count bottle (NDC 68788-7595-9); 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 (14)

  • Lot # a) D2022P
  • Exp. Date:4/30/2023
  • F1022Y
  • E2022
  • I2822U
  • Exp. Date:6/30/2023
  • L2122W
  • Exp. Date: 8/31/2024
  • b) Lot #L0522A
  • Exp. Date:8/31/2024
  • B0823J
  • Exp. Date:11/31/2024
  • c) Lot# L1522P
  • Exp. Date: 10/31/2024.

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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