The Recall Desk
ModerateFDA (Drugs)·D-0642-2022·Announced 2022-03-09

Alprazolam Tablets 1mg Recalled for CGMP Deviations

Preferred Pharmaceuticals is recalling 276 bottles of Alprazolam Tablets USP 1mg (generic Xanax) distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.

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 for CGMP deviations. No illnesses, injuries, or specific product defects are reported in the source text. The source text does not indicate any actual harm or high-risk contamination, making this a precautionary manufacturing quality recall rather than a direct safety hazard.

Plain-English summary

Preferred Pharmaceuticals, Inc. is voluntarily recalling Alprazolam Tablets, USP 1mg (a generic form of Xanax) in three package sizes: 30-tablet bottles (NDC 68788-6381-03), 60-tablet bottles (NDC 68788-6381-06), and 90-tablet bottles (NDC 68788-6381-09). A total of 276 bottles have been distributed nationwide in the USA. The recall was initiated on February 22, 2022, and was classified by the FDA as Class II.

The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected lot numbers are: G2919M, I0619O, and F1419J (30-tablet bottles); H3019Q (60-tablet bottles); and F1219N, F1919D, H0219D, I0519R, and J0319G (90-tablet bottles), all with an expiration date of March 31, 2022.

Consumers who have purchased this medication should stop use and consult with their pharmacy or healthcare provider about next steps, including potential replacement medication or refunds. The FDA classified this recall as Class II because it is a voluntary, firm-initiated recall for manufacturing deviations that could result in drug quality issues.

The recalled product

Product
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Benzodiazepine
Hazard
  • 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 (10)

  • Lot #s: a) G2919M
  • I0619O
  • F1419J
  • b) H3019Q
  • c) F1219N
  • F1919D
  • H0219D
  • I0519R
  • J0319G
  • Exp. 03/31/2022.

Distribution

Distributed nationwide across the United States.

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