PD-Rx Pharmaceuticals, Inc. recalls Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated
PD-Rx Pharmaceuticals recalls 4mg Glimepiride USP bottles due to CGMP deviations. Affected lots have specific expiration dates and NDC numbers. Consumers should contact the manufacturer for details.
Recall notice
CGMP deviations.
Contact the company & request your remedy
What happened, in plain English
PD-Rx Pharmaceuticals is recalling 4mg Glimepiride USP bottles that were made with CGMP deviations. This means the medication may not be safe or effective. People with diabetes who use this prescription drug should check if their bottle is affected. Read more at govinfonow.com/recall/33738-pd-rx-glimepiride-4mg-bottles-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/33738-pd-rx-glimepiride-4mg-bottles-recall-cgmp-deviations · Updated September 23, 2026 · FDA enforcement record: FDA #D-0559-2023
Cite this page
“PD-Rx Glimepiride 4mg Bottles Recall: CGMP Deviations.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33738-pd-rx-glimepiride-4mg-bottles-recall-cgmp-deviations. Based on FDA recall #D-0559-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0559-2023%22&limit=1).
Why it’s dangerous
CGMP deviations refer to failures in the manufacturing process that could affect the drug's safety or effectiveness. This means the medication might not work as intended or could be harmful. However, the exact risk level isn't clearly stated in the recall.
Who’s affected
People with diabetes who use Glimepiride USP 4mg 90-count bottles prescribed by a doctor. Those who received the recalled lots from the specific manufacturers listed are most at risk.
How to tell if you have this one
Check the bottle for the NDC number 43063-0587-90 and expiration dates listed: January 31, 2024, March 31, 2024, or October 31, 2024. The product was sold by Intas Pharm. Limited under PD-Rx Pharmaceuticals Incorporated.
- Brand
PD-Rx Pharmaceuticals- Category
Drug
All 5 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 US.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0557-2023 | Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30; Lots: L22C80, I22D93, K21C72 Exp. 11/30/23; A23A90, B23A09 Exp. 07/31/24; K22C33 Exp. 05/31/24; G22E88, G22F66, I22E27, C22B27, D22B94, E22C71 Exp. 02/28/24; I21E36 Exp. 09/30/23 | 352 bottles |
| D-0558-2023 | Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90); Lots: a) K22E32 Exp. 10/31/23; b) H22C33 Exp. 09/30/23; H22C81, J22C83, K22E36 Exp. 10/31/23 | 37 bottles |
| D-0559-2023 | Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90; Lots: A22B45 Exp. 01/31/24; C22A73, E22E41, C22D28, F22B68, G22A29, H22B97, K22A36 Exp. 03/31/24; K22B99, A23D07, B23B25 Exp. 10/31/24; B23B55 Exp. 06/30/25 | 186 bottles |
| D-0560-2023 | Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90); Lots: a) G22B32, D22B92, D22F82, Exp. 06/30/23; G22F41, J22F25, L22C14, Exp. 01/31/24; D22B92, D22F82 Exp. 06/30/23; B22A12, Exp. 03/31/23 b) H22A32, I22E83, J22E94, K22E34 Exp. 01/31/24; C22F31, D22G16, E22D75, F22E06, Exp. 06/30/23; L21E09, B22C61, Exp. 01/31/23. | 520 bottles |
| D-0561-2023 | Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90); Lots: a) A22A17, D22C21 Exp. 07/31/23; K22D89, L22B26, L22D14 Exp. 03/31/24; L22D96 Exp. 04/30/24; b) L21E06 Exp. 05/31/23; B22C05, D22B91, E22C82 Exp. 07/31/23; G22B03 G22B79, H22A30, J22B81 Exp. 08/31/23; J22F27, K22B37, K22B88 Exp. 10/31/23; L22D32 Exp. 03/31/24; B23E07 Exp. 04/30/24 | 393 bottles |
What to do — step by step
Check Product Details
Look for the NDC number 43063-0587-90 and expiration dates on the bottle label.
Questions people ask
Is this medication safe to use?
The recall states there were CGMP deviations, which could affect safety or effectiveness, but the exact risk isn't clear. The manufacturer recommends checking if your bottle is affected.
How do I know if my bottle is affected?
Check for the NDC number 43063-0587-90 and expiration dates listed: January 31, 2024, March 31, 2024, or October 31, 2024.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact PD-Rx Pharmaceuticals for further instructions.
Contact PD-Rx Pharmaceuticals
We’ve drafted a message you can send PD-Rx Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0559-2023 — PD-Rx Pharmaceuticals PD-Rx Pharmaceuticals Hello, I own a PD-Rx Pharmaceuticals that is covered by recall D-0559-2023 from PD-Rx Pharmaceuticals. 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-0559-2023 (April 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0559-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.