Direct Rx Glimepiride Tablets Recall: CPG Deviations Risk
Direct Rx recalls 1 mg Glimepiride tablets (NDC 61919-0723-30 and 61919-0723-90) due to cGMP deviations. Affected lots expire by 5/31/2024 and 1/31/2024. Consumers should check their bottles for lot numbers.
Recall notice
cGMP deviations
Contact the company
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. Read more at govinfonow.com/recall/33810-direct-rx-glimepiride-tablets-recall-cpg-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33810-direct-rx-glimepiride-tablets-recall-cpg-deviations-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0480-2023
Cite this page
“Direct Rx Glimepiride Tablets Recall: CPG Deviations Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33810-direct-rx-glimepiride-tablets-recall-cpg-deviations-risk. Based on FDA recall #D-0480-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0480-2023%22&limit=1).
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
All 11 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
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0476-2023 | Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30 count bottles] Lot, expiry: 20JU2211, exp 5/31/2024; b) [90 count bottles] Lot, expiry: 25JU2128 , exp 12/31/2023; 13SE2132 , exp 12/31/2023; 25JU2133 , exp 12/31/2023; 16JU2127 , exp 12/31/2023; 18MY2126 , exp 12/31/2023; 10JU2111 , exp 12/31/2023; 14SE2111 , exp 1/31/2024 ; 14JY2115 , exp 1/31/2024 ; 25OC2113 , exp 2/29/2024 ; 21SE2227 , exp 2/29/2024 ; 10DE2123 , exp 3/31/2024 ; 22NO2115 , exp 3/31/2024 ; 21JA2202 , exp 4/30/2024 ; 29DE2110 , exp 4/30/2024 ; 28FE2227 , exp 4/30/2024 ; 06JU2208 , exp 5/31/2024 ; 30MA2229 , exp 5/31/2024 ; 30AU2216 , exp 6/30/2024 ; 23NO2203 , exp 6/30/2024 ; 14DE2216 , exp 7/31/2025 ; 12JA2305 , exp 7/31/2025 . | 90 count: 495 bottles; 30 count: 13 bottles |
| D-0477-2023 | Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx; Lot, expiry: 19AU2205, exp 12/31/24; 12OC2211, exp 12/31/24 | 19 bottles |
| D-0478-2023 | Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; Lot, expiry: 21JU2210, exp 7/31/23 | 9 bottles |
| D-0479-2023 | Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; Lot, expiry: 22JU2216 , exp 8/31/23 | 4 bottles |
| D-0480-2023 | Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC 61919-0723-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30 count bottles] Lot, expiry: 07MA2208, exp 5/31/2024 b) [90 count bottles] Lot, expiry: 09AU2128 , exp 1/31/2024; 28JY2102 , exp 1/31/2024; 06AU2103 , exp 1/31/2024 ; 03JA2210 , exp 1/31/2024 ; 14JY2114 , exp 1/31/2024 ; 05NO2106 , exp 2/29/2024 ; 13OC2118 , exp 2/29/2024 ; 08DE2121 , exp 2/29/2024 ; | 30 count: 4 bottles; 90 count: 172 bottles |
| D-0481-2023 | Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30 count bottles] Lot, expiry: 21JU2112 , exp 9/30/2023 b) [90 count bottles] Lot, expiry: 22DE2113 , exp 1/31/2024; 27JA2235 , exp 3/31/2024; 05AP2224 , exp 7/31/2024 ; 06AU2104 , exp 1/31/2024 ; 08JU2215 , exp 9/30/2024 ; 209AU2109 , exp 1/31/2024 ; 15JU2113 , exp 9/30/2023 ; 21FE2217 , exp 4/30/2024 ; 21OC2115 , exp 2/29/2024 ; 23JY2144 , exp 1/31/2024 ; 25JU2124 , exp 9/30/2023 ; 29AP2219 , exp 7/31/2024 ; 07DE2128 , exp 3/31/2024 . | 30 count: 12 bottles; 90 count: 253 bottles |
| D-0482-2023 | Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC 61919-0250-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30 count bottles] Lot, expiry: 13DE2111 , exp 3/31/2024 b) [90 count bottles] Lot, expiry: 17NO2116 , exp 1/31/2024 ; 27JA2234 , exp 4/30/2024; 02MA2218, exp 6/30/2024 ; 12MY2211, exp 7/31/2024 ; 13JY2107, exp 10/31/2023; 15AP2221 , exp 7/31/2024 ; 17AU2110 , exp 10/31/2023; 20SE2108 , exp 10/31/2023; 23JU2115 , exp 10/31/2023; 28JY2101 ,exp 10/31/2023; 30JY2101 ,exp 10/31/2023; 05JA2212 , exp 3/31/2024 ; 13DE2130 , exp 3/31/2024 ; 21OC2111, exp 1/31/2024 ; 17NO2116 , exp 3/31/2024 . | 30 count: 7 bottles; 90 count: 395 bottles |
| D-0483-2023 | Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; Lot, expiry: 03JA2209, 28FE2225, 28AP2211, 07AP2203, exp 6/30/23 | 51 bottles |
| D-0484-2023 | Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30-count bottles] Lot, expiry: 05AU2206, exp 10/31/23; b) [90-count bottles] Lot, expiry: 30MA2213, exp 6/30/23; 10DE2124, exp 3/31/23; 15MA2224, exp 5/32/23; 27JA2229, exp 3/31/23. | 30 count: 6 bottles; 90 count: 106 bottles |
| D-0485-2023 | Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; a) [30-count bottles] Lot, expiry: 09JA2312 , exp 2/28/2025; b) [90-count bottles] Lot, expiry: 22OC2111, exp 1/31/2023; 13OC2120, exp 3/31/2023; 16JY2104, exp 12/31/2023; 09AU2125 , exp 1/31/2024 ; 28JY2125 , exp 1/31/2024 ; 23SE2115 , exp 3/31/2024 ; 23SE2115 , exp 3/31/2024 ; 07JA2211 , exp 5/31/2024 ; 27JA2214 , exp 5/31/2024 ; 15AP2224 , exp 6/30/2024 ; 24MA2221 , exp 6/30/2024 ; 16AU2214 , exp 6/30/2024 . | 30 count: 5 bottles; 90 count: 53 bottles |
| D-0486-2023 | Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534; Lot, expiry: 28AP2212 , exp 7/31/2024 ; 24MA2230, exp 7/31/2024; 11JA2203 , exp 3/31/2023; 02FE2217 , exp 2/28/2023; 10DE2126 , exp 2/28/2023; 25MA2201, exp 5/31/2023; 28FE2230, exp 5/31/2023. | 269 bottles |
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.
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 terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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.