CLASS II Drug recall · Reported 10 May 2023 · FDA Enforcement Report

Glimepiride USP, 4 mg-bottles recalled by PD-Rx Pharmaceuticals

PD-Rx Pharmaceuticals is recalling Glimepiride USP, 4 mg-bottles, distributed nationwide in the US. The recall was initiated on 6 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 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

Quantity recalled186 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0559-2023
FDA event ID: 92081
Recalling firm: PD-Rx Pharmaceuticals, Oklahoma City, OK
Classification: Class II
Status: Terminated
Recall initiated: 6 Apr 2023
FDA classified: 1 May 2023
Reported: 10 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Diabetes Medication

Timeline

6 Apr 2023	Recall initiated by company
1 May 2023	Classified by FDA	+25 days
10 May 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP deviations.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the US.

Nationwide

Questions about this recall

Why was it recalled?

CGMP deviations.

Which lots are affected?

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

Where was it sold?

Nationwide in the US.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 92081

Reported	Class	Recall	Company	Reason	Where
10 May 2023	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023	CLASS II	Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from PD-Rx Pharmaceuticals

All 25

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025Drug	CLASS II	DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Nitrosamine Impurity	FL, MS, WI
10 May 2023Drug	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Other Glimepiride recalls

All 19

Reported	Class	Recall	Company	Reason	Where
14 Feb 2024Drug	CLASS III	Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride	Dr. Reddy's Laboratories	Other	Nationwide
14 Feb 2024Drug	CLASS III	Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride	Dr. Reddy's Laboratories	Other	Nationwide
31 May 2023Drug	CLASS II	Glimepiride Tablets, USP, 1 mg, RX, Packaged as a) recalled	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
31 May 2023Drug	CLASS II	Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) recalled	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide
31 May 2023Drug	CLASS II	Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) recalled	Amerisource Health Services	Manufacturing (CGMP) Deviations	Nationwide