Direct Rx Glimepiride Tablets Recall: CPG Deviations Risk

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Direct Rx is recalling 1 mg Glimepiride tablets that were made with cGMP deviations. This means the tablets might not be safe or effective as intended. If you have these tablets, you should stop using them and contact the manufacturer.

Why it’s dangerous

The tablets were produced with cGMP deviations, which are quality control issues that could affect safety and effectiveness. This means the medication might not work as intended or could be harmful.

Who’s affected

People who have the recalled 1 mg Glimepiride tablets (NDC 61919-0723-30 or 61919-0723-90) from Direct Rx. Those with diabetes who take these tablets are most at risk.

How to tell if you have this one

Check your Glimepiride tablets for the lot numbers listed: 07MA2208 (exp 5/31/2024) or 09AU2128, 28JY2102, 06AU2103, 03JA2210, 14JY2114, 05NO2106, 13OC2118, 08DE2121 (all exp 1/31/2024 or 2/29/2024).

Brand
Direct Rx
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Tablets
Look for the lot numbers on the bottle: 07MA2208 (exp 5/31/2024) or 09AU2128, 28JY2102, 06AU2103, 03JA2210, 14JY2114, 05NO2106, 13OC2118, 08DE2121 (exp 1/31/2024 or 2/29/2024).
Stop Using Immediately
If you have the recalled tablets, stop using them right away and contact Direct Rx for instructions.

✎ GovInfoNow

Questions people ask

What is the recall for?

Direct Rx is recalling 1 mg Glimepiride tablets (NDC 61919-0723-30 and 61919-0723-90) due to cGMP deviations.

How can I tell if I have the recalled product?

Check your tablets for lot numbers: 07MA2208 (exp 5/31/2024) or 09AU2128, 28JY2102, 06AU2103, 03JA2210, 14JY2114, 05NO2106, 13OC2118, 08DE2121 (exp 1/31/2024 or 2/29/2024).

What should I do if I have the recalled tablets?

Stop using the tablets immediately and contact Direct Rx for instructions.

Take action

Contact Direct Rx

We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0480-2023 — Direct Rx Direct Rx

Hello,

I own a Direct Rx that is covered by recall D-0480-2023 from Direct Rx.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-0480-2023 (March 13, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0480-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Direct Rx recalls Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC

Recall notice