Use caution Drug recall · FDA · Published March 22, 2023

Direct Rx Alprazolam Recall: Cross-Contamination Risk

Direct Rx is recalling specific lots of Alprazolam 1 mg tablets due to potential cross-contamination. Check your bottle's NDC and lot number immediately.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0508-2023Drug Direct Rx ›

Use caution until it’s fixed

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Take action

Contact the company

Recalling firmDirect Rx94 Worldwide Dr · Dawsonville, GA 30534-6828

✎ GovInfoNow plain-language explainer

Direct Rx is recalling Alprazolam C-IV, 1 mg tablets because the repackaging firm had potential product cross-contamination concerns at the manufacturer. The recall affects specific lots distributed nationwide in the USA. No remedy or return instructions are currently stated in the record. Read more at govinfonow.com/recall/33775-direct-rx-alprazolam-recall-cross-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33775-direct-rx-alprazolam-recall-cross-contamination-risk · Updated October 10, 2026 · FDA enforcement record: FDA #D-0508-2023

Cite this page

“Direct Rx Alprazolam Recall: Cross-Contamination Risk.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/33775-direct-rx-alprazolam-recall-cross-contamination-risk. Based on FDA recall #D-0508-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0508-2023%22&limit=1).

The FDA announced on March 22, 2023, that Direct Rx is voluntarily recalling Alprazolam C-IV, 1 mg tablets due to potential product cross contamination concerns. The recall involves specific lots of the drug distributed nationwide.

How to tell if you have it

Brand: Direct Rx
Product: Alprazolam 1 mg Tablets
NDC 72189-213-30 (30 Tabs per bottle)
NDC 72189-213-60 (60 Tabs per bottle)
Lots: 03FE2318, 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, 17FE2203, 12AP2204, 17MA2205, 21JU2206, 22JU2220, 12JY2206, 10AU2209, 14DE2215, 05JA2304, 27JA2301
Quantity: 349 bottles

The hazard

The repackaging firm is recalling the product due to potential product cross contamination concerns at the manufacturer. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Direct Rx has 19 other recalls on record since March 12, 2019. Other recent recalls of similar products include Direct Rx DULOXETINE D/R 30mg Caps Recall (June 22, 2026), Direct Rx Duloxetine 30mg Capsules Recall (March 7, 2025), and Direct Rx Ciprofloxacin Ophthalmic Solution Recall (Jan. 31, 2025).

How to tell if you have this one

Check your prescription bottle for NDC 72189-213-30 (30 Tabs) or NDC 72189-213-60 (60 Tabs). Verify the lot number against the recalled lots: 03FE2318, 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, 17FE2203, 12AP2204, 17MA2205, 21JU2206, 22JU2220, 12JY2206, 10AU2209, 14DE2215, 05JA2304, or 27JA2301.

Brand
Direct Rx
Category
Drug

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity
D-0507-2023	Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0240-30.; Lot: 11AP2219 Exp. 4/30/23	20 bottles
D-0508-2023	Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.; Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.	349 bottles
D-0509-2023	Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-121-60.; Lots: 03FE2319 Exp. 2/28/25, 13MY2217 Exp. 5/31/23	9 bottles

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Verify if your Alprazolam bottle matches the recalled NDCs and lot numbers listed in the record.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacy or healthcare provider for guidance on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Mar 22, 2023Firm started the recall
Apr 6, 2023FDA classified it Class II
Apr 12, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Direct Rx recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33775-direct-rx-alprazolam-recall-cross-contamination-risk">Direct Rx Alprazolam Recall: Cross-Contamination Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0508-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0508-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.