CLASS II ONGOING Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report

Simvastatin Tablets, USP, 80 mg recalled by Preferred Pharmaceuticals

Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 80 mg, distributed nationwide in the US. The recall was initiated on 23 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023.

Quantity recalled57 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-0523-2023
FDA event ID: 91952
Recalling firm: Preferred Pharmaceuticals, Anaheim, CA
Classification: Class II
Status: Ongoing
Recall initiated: 23 Mar 2023
FDA classified: 6 Apr 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Cholesterol Medication

Timeline

23 Mar 2023	Recall initiated by company
6 Apr 2023	Classified by FDA	+14 days
12 Apr 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 for the manufacturing Firm (Accord Healthcare) after their inspection.

Product as listed by the FDA

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Which lots are affected?

Lot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023.

Where was it sold?

USA Nationwide

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

16 other products · FDA event 91952

This product is part of a recall event; the main page for the event is Doxazosin Tablets, USP, 4 mg recalled by Preferred Pharmaceuticals.

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023	CLASS II	Doxazosin Tablets, USP, 4 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Glimepiride Tablets USP, 4 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Atorvastatin Calcium Tablets, USP, 10 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Rosuvastatin Tablets, USP, 5mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Tadalafil Tablets, USP, 20 mg recalled by Preferred PharmaceuticalsTadalafil	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Montelukast Sodium Tablets, USP, 10 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Atorvastatin Calcium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Pravastatin Sodium Tablets, USP, 20 mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Simvastatin Tablets, USP, 10 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Glimepiride Tablets, USP, 2 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Clopidogrel Tablets USP, 75 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Doxazosin Tablets, USP, 2 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023	CLASS II	Finasteride Tablets, USP, 5 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Preferred Pharmaceuticals

All 55

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears	Preferred Pharmaceuticals	Sterility	Nationwide
24 Dec 2025Drug	CLASS II	Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled	Preferred Pharmaceuticals	Packaging Defects	CA
7 May 2025Drug	CLASS II	Clindamycin Hydrochloride Capsules, USP, 300mg recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV
29 May 2024Drug	CLASS II	Duloxetine Delayed-Release Cap USP 30mg recalled	Preferred Pharmaceuticals	Nitrosamine Impurity	5 states

Other Simvastatin recalls

All 29

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