CLASS II Drug recall · Reported 31 May 2023 · FDA Enforcement Report

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) recalled

Amerisource Health Services is recalling Glimepiride Tablets, USP, 4 mg, RX, Packaged as a), distributed nationwide in the US. The recall was initiated on 17 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatches a) P2003403, EXP 05/31/2023; P2006593, EXP 11/30/2023; P2101152, EXP 01/31/2024; P2105014, EXP 06/30/2024; R2101440, EXP 09/30/2024; P2200774, EXP 01/31/2025; R2200664, EXP 04/30/2025 b) P2100705, EXP 01/31/2024; P2104672, EXP 06/30/2024; R2101435, EXP 09/30/2024; R2200102, EXP 12/31/2024; R2200577, EXP 04/30/2025; P2205870, EXP 08/31/2025 [500 count] Lot, expiry: P2100121, exp 11/30/2023; P2100705, exp 01/31/2024; P2104672, exp 06/30/2024; R2101435, exp 09/30/2024; R2200102, exp 12/31/2024; R2200577, exp R2200577;P2205870, exp 08/31/2025

Quantity recalled129,849 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-0759-2023
FDA event ID: 92058
Recalling firm: Amerisource Health Services, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 17 Mar 2023
FDA classified: 19 May 2023
Reported: 31 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Diabetes Medication

Timeline

17 Mar 2023	Recall initiated by company
19 May 2023	Classified by FDA	+63 days
31 May 2023	Published in enforcement report	+12 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: recalling drug products following an FDA inspection.

Product as listed by the FDA

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

Where it was distributed

Nationwide USA

Nationwide

Questions about this recall

Is Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) recalled?

Yes. Amerisource Health Services recalled Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) on 17 Mar 2023. The recall is Class II and its status is Terminated. Recall number D-0759-2023.

Why was it recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Which lots are affected?

Batches a) P2003403, EXP 05/31/2023; P2006593, EXP 11/30/2023; P2101152, EXP 01/31/2024; P2105014, EXP 06/30/2024; R2101440, EXP 09/30/2024; P2200774, EXP 01/31/2025; R2200664, EXP 04/30/2025 b) P2100705, EXP 01/31/2024; P2104672, EXP 06/30/2024; R2101435, EXP 09/30/2024; R2200102, EXP 12/31/2024; R2200577, EXP 04/30/2025; P2205870, EXP 08/31/2025 [500 count] Lot, expiry: P2100121, exp 11/30/2023; P2100705, exp 01/31/2024; P2104672, exp 06/30/2024; R2101435, exp 09/30/2024; R2200102, exp 12/31/2024; R2200577, exp R2200577;P2205870, exp 08/31/2025

Where was it sold?

Nationwide USA

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

More recalls from Amerisource Health Services

All 69

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Glimepiride recalls

All 16

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
10 May 2023Drug	CLASS II	Glimepiride USP, 4 mg-bottles recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide