Medications & Supplements/Prescription Drugs

Direct Rx Alprazolam Recalled for Potential Cross-Contamination

Agency Publication Date: April 6, 2023

Summary

Direct Rx is recalling 378 bottles of Alprazolam (alprazolam) C-IV tablets in 0.5 mg, 1 mg, and 2 mg strengths. This recall was initiated due to potential product cross-contamination concerns at the manufacturing facility. If you have been prescribed this medication, please check your bottle to see if it is part of the affected batches.

Risk

The manufacturer reported deviations from good manufacturing practices that may have led to cross-contamination with other drug products. Consuming a contaminated medication could lead to unintended drug exposure or adverse health effects.

What You Should Do

The recalled products are Alprazolam C-IV tablets in 0.5 mg (30-count bottles), 1 mg (30 and 60-count bottles), and 2 mg (60-count bottles) strengths distributed by Direct Rx.
Identify your product by checking the NDC numbers 72189-0240-30, 72189-213-30, 72189-213-60, or 72189-121-60 and the lot number printed on the label. See the Affected Products section below for the full list of affected codes.
If you have health concerns or are unsure about your medication, 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 directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 (0.5 mg)

Variants: 0.5 mg, 30 Tabs per bottle

Lot Numbers:

11AP2219 (Exp. 4/30/23)

NDC:

72189-0240-30

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Product: Alprazolam C-IV (1 mg)

Variants: 1 mg, 30 Tabs per bottle, 60 Tabs per bottle

Lot Numbers:

03FE2318 (Exp. 8/31/24)

27FE2315 (Exp. 8/31/24)

28FE2313 (Exp. 8/31/24)

02MA2306 (Exp. 8/31/24)

21SE2201 (Exp. 8/31/24)

16NO2216 (Exp. 8/31/24)

17NO2216 (Exp. 8/31/24)

24FA2314 (Exp. 8/31/24)

17FE2203 (Exp. 3/31/23)

12AP2204 (Exp. 3/31/23)

17MA2205 (Exp. 3/31/23)

21JU2206 (Exp. 5/31/23)

22JU2220 (Exp. 5/31/23)

12JY2206 (Exp. 5/31/23)

10AU2209 (Exp. 6/30/23)

14DE2215 (Exp. 9/30/24)

05JA2304 (Exp. 11/30/24)

27JA2301 (Exp. 11/30/24)

NDC:

72189-213-30

72189-213-60

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Product: Alprazolam C-IV (2 mg)

Variants: 2 mg, 60 Tabs per bottle

Lot Numbers:

03FE2319 (Exp. 2/28/25)

13MY2217 (Exp. 5/31/23)

NDC:

72189-121-60

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92054

Status: Active

Manufacturer: Direct Rx

Manufactured In: United States

Units Affected: 3 products (20 bottles; 349 bottles; 9 bottles)

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

The recalled products are Alprazolam C-IV tablets in 0.5 mg (30-count bottles), 1 mg (30 and 60-count bottles), and 2 mg (60-count bottles) strengths distributed by Direct Rx.

Identify your product by checking the NDC numbers 72189-0240-30, 72189-213-30, 72189-213-60, or 72189-121-60 and the lot number printed on the label. See the Affected Products section below for the full list of affected codes.

If you have health concerns or are unsure about your medication, 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 directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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 (0.5 mg)

Variants: 0.5 mg, 30 Tabs per bottle

Lot Numbers:

11AP2219 (Exp. 4/30/23)

NDC:

72189-0240-30

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Product: Alprazolam C-IV (1 mg)

Variants: 1 mg, 30 Tabs per bottle, 60 Tabs per bottle

Lot Numbers:

03FE2318 (Exp. 8/31/24)

27FE2315 (Exp. 8/31/24)

28FE2313 (Exp. 8/31/24)

02MA2306 (Exp. 8/31/24)

21SE2201 (Exp. 8/31/24)

16NO2216 (Exp. 8/31/24)

17NO2216 (Exp. 8/31/24)

24FA2314 (Exp. 8/31/24)

17FE2203 (Exp. 3/31/23)

12AP2204 (Exp. 3/31/23)

17MA2205 (Exp. 3/31/23)

21JU2206 (Exp. 5/31/23)

22JU2220 (Exp. 5/31/23)

12JY2206 (Exp. 5/31/23)

10AU2209 (Exp. 6/30/23)

14DE2215 (Exp. 9/30/24)

05JA2304 (Exp. 11/30/24)

27JA2301 (Exp. 11/30/24)

NDC:

72189-213-30

72189-213-60

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534

Product: Alprazolam C-IV (2 mg)

Variants: 2 mg, 60 Tabs per bottle

Lot Numbers:

03FE2319 (Exp. 2/28/25)

13MY2217 (Exp. 5/31/23)

NDC:

72189-121-60

Packaged and Distributed By: Direct Rx Dawsonville, GA 30534