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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Alprazolam Tablets Recalled for Potential Cross-Contamination

Agency Publication Date: March 10, 2022
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Summary

Direct Rx is recalling 24 bottles of Alprazolam C-IV (1 mg and 2 mg) tablets because of potential cross-contamination that occurred at the contract manufacturing facility, Ultra Tab Laboratories Inc. Alprazolam is a prescription medication used to treat anxiety and panic disorders. The recall involves approximately 16 bottles of the 1 mg strength and 8 bottles of the 2 mg strength distributed in Florida, Louisiana, and Georgia. No incidents or injuries have been reported to date.

Risk

Cross-contamination in pharmaceutical manufacturing can introduce unintended active ingredients into a medication, which may lead to unexpected side effects or dangerous interactions with other drugs. Because this is a controlled substance, the presence of foreign contaminants could pose moderate health risks to consumers.

What You Should Do

  1. This recall affects Alprazolam C-IV 1 mg (NDC 61919-836-60) and Alprazolam C-IV 2 mg (NDC 72189-0058-60) sold in 60-count bottles and distributed by Par Pharmaceutical and Direct Rx.
  2. Check your prescription bottles for lot number 19AU1910 (for 1 mg tablets) or lot number 07NO1901 (for 2 mg tablets), both with an expiration date of 5/31/22.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Direct Rx for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Alprazolam C-IV 1 mg (60-count bottles)
Variants: 1 mg, Tablet
Lot Numbers:
19AU1910 (Exp. 5/31/22)
NDC:
61919-836-60

Recall #: D-0650-2022; Dist. By: Par Pharmaceutical; Packaged and Distributed By: Direct Rx

Product: Alprazolam C-IV 2 mg (60-count bottles)
Variants: 2 mg, Tablet
Lot Numbers:
07NO1901 (Exp. 5/31/22)
NDC:
72189-0058-60

Recall #: D-0651-2022; Dist. By: Par Pharmaceutical; Packaged and Distributed By: Direct Rx

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89749
Status: Resolved
Manufacturer: Direct Rx
Sold By: Par Pharmaceutical; Direct Rx
Manufactured In: United States
Units Affected: 2 products (16 bottles; 8 bottles)
Distributed To: Florida, Georgia, Louisiana

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.