CLASS II Drug recall · Reported 8 Mar 2023 · FDA Enforcement Report

Simvastatin Tablets USP 40 mg recalled by Accord Healthcare

Accord Healthcare is recalling Simvastatin Tablets USP 40 mg, distributed in Puerto Rico. The recall was initiated on 7 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R2101339, Exp. Date 9/30/2023, R2101494, R2101495, R2101496, R2101497, Exp. Date 10/31/2023, R2200527, R2200531, Exp. Date 3/31/2024, R2200606, R2200625, Exp. Date 4/30/2024; b) P2101911, P2101913, R2100344, R2100351, R2100354, R2100346, R2100357, R2100358, R2100359, R2100361, R2100362, R2100385, R2100386, R2100388, R2100394, R2100397, R2100345, Exp. Date 2/28/2023; P2101930, P2101983, R2100435, R2100457, R2100433, R2100462, R2100466, R2100465, R2100469, R2100468, Exp. Date 3/31/2023; P2103223, P2103229, P2103234, Exp. Date 4/30/2023; P2103254, P2103258, P2103261, P2103323, P2103362, P2103364, P2103310, P2103671, P2103678, P2103545, P2103568, P2103599, P2103616, P2103627, P2103649, P2103813, P2103832, P2103834, P2103867, P2103868, P2103901, P2103912, Exp. Date 5/31/2023; P2105024, P2105027, P2105028, P2105049, P2105047, P2105052, P2105340, P2105341, P2105420, P2105432, P2105445, P2105455, P2105456, P2105467, P2105461, Exp. Date 7/31/2024; R2101118, R2101119, R2101127, R2101128, R2101134, R2101145, R2101133, R2101146, R2101149, R2101164, R2101169, R2101165, R2101187, R2101188, R2101192, R2101193, R2101168, R2101194, Exp. Date 8/31/2024; R2101516, R2101517, R2101515, R2101523, R2101525, R2101524, R2101530, R2101531, R2101532, R2101534, R2101533, R2101541, R2101547, R2101569, R2101567, R2101568, R2101571, R2101580, R2101582, R2101592, R2101583, R2101581, R2101593, P2107446, Exp. Date 10/31/2024; P2107791, P2107792, Exp. Date 11/30/2024; R2200271, R2200272, R2200275, Exp. Date 1/31/2025; R2200374, R2200379, R2200378, R2200391, Exp. Date 2/28/2025; R2200457, R2200458, R2200540, R2200470, R2200541, R2200459, R2200451, R2200471, Exp. Date 3/31/2025; R2200610, R2200611, R2200616, R2200615,R2200624, R2200628, R2200736, Exp. Date 4/30/2025, R2200688, R2200681, R2200687, Exp. Date 5/31/2025;

NDC16729-004, 16729-005, 16729-006, 16729-007, 16729-156

UPC316729006156, 316729006170

Quantity recalled1,190,484 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-0411-2023
FDA event ID: 91657
Recalling firm: Accord Healthcare, Durham, NC
Brand: Simvastatin
Manufacturer: Accord Healthcare, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 7 Feb 2023
FDA classified: 2 Mar 2023
Reported: 8 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Cholesterol Medication

Timeline

7 Feb 2023	Recall initiated by company
2 Mar 2023	Classified by FDA	+23 days
8 Mar 2023	Published in enforcement report	+6 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

Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Where it was distributed

United States including Puerto Rico and Canada

Puerto Rico

Questions about this recall

Is Simvastatin Tablets USP 40 mg recalled?

Yes. Accord Healthcare recalled Simvastatin Tablets USP 40 mg on 7 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0411-2023.

Why was it recalled?

CGMP Deviations: recalling drug products following an FDA inspection.

Which lots are affected?

Batches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R2101339, Exp. Date 9/30/2023, R2101494, R2101495, R2101496, R2101497, Exp. Date 10/31/2023, R2200527, R2200531, Exp. Date 3/31/2024, R2200606, R2200625, Exp. Date 4/30/2024; b) P2101911, P2101913, R2100344, R2100351, R2100354, R2100346, R2100357, R2100358, R2100359, R2100361, R2100362, R2100385, R2100386, R2100388, R2100394, R2100397, R2100345, Exp. Date 2/28/2023; P2101930, P2101983, R2100435, R2100457, R2100433, R2100462, R2100466, R2100465, R2100469, R2100468, Exp. Date 3/31/2023; P2103223, P2103229, P2103234, Exp. Date 4/30/2023; P2103254, P2103258, P2103261, P2103323, P2103362, P2103364, P2103310, P2103671, P2103678, P2103545, P2103568, P2103599, P2103616, P2103627, P2103649, P2103813, P2103832, P2103834, P2103867, P2103868, P2103901, P2103912, Exp. Date 5/31/2023; P2105024, P2105027, P2105028, P2105049, P2105047, P2105052, P2105340, P2105341, P2105420, P2105432, P2105445, P2105455, P2105456, P2105467, P2105461, Exp. Date 7/31/2024; R2101118, R2101119, R2101127, R2101128, R2101134, R2101145, R2101133, R2101146, R2101149, R2101164, R2101169, R2101165, R2101187, R2101188, R2101192, R2101193, R2101168, R2101194, Exp. Date 8/31/2024; R2101516, R2101517, R2101515, R2101523, R2101525, R2101524, R2101530, R2101531, R2101532, R2101534, R2101533, R2101541, R2101547, R2101569, R2101567, R2101568, R2101571, R2101580, R2101582, R2101592, R2101583, R2101581, R2101593, P2107446, Exp. Date 10/31/2024; P2107791, P2107792, Exp. Date 11/30/2024; R2200271, R2200272, R2200275, Exp. Date 1/31/2025; R2200374, R2200379, R2200378, R2200391, Exp. Date 2/28/2025; R2200457, R2200458, R2200540, R2200470, R2200541, R2200459, R2200451, R2200471, Exp. Date 3/31/2025; R2200610, R2200611, R2200616, R2200615,R2200624, R2200628, R2200736, Exp. Date 4/30/2025, R2200688, R2200681, R2200687, Exp. Date 5/31/2025;

Where was it sold?

United States including Puerto Rico and Canada

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.

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2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 112 mcg 112 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 88 mcg 088 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 100 mcg 1 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 175 mcg 175 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide
2 Sep 2026Drug	CLASS II	Levothyroxine Sodium Tablets, USP, 150 mcg 15 mg) recalledLevothyroxine Sodium	Accord Healthcare	Potency & Assay	Nationwide

Other Simvastatin recalls

All 21

Reported	Class	Recall	Company	Reason	Where
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
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide