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
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
Questions about this recall
Is Simvastatin Tablets, USP, 80 mg recalled?
Yes. Preferred Pharmaceuticals recalled Simvastatin Tablets, USP, 80 mg on 23 Mar 2023. The recall is Class II and its status is Ongoing. Recall number D-0523-2023.
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 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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|---|---|---|---|---|---|
| Drug | CLASS II | Artificial Tears Lubricant Eye Drops (glycerin recalledArtificial Tears | Preferred Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Ondansetron ODT Tablets, USP 4mg, unit dose tablets, Mfg recalled | Preferred Pharmaceuticals | Packaging Defects | CA |
| Drug | CLASS II | Clindamycin Hydrochloride Capsules, USP, 300mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS II | Duloxetine Delayed-Release Cap USP 30mg recalled | Preferred Pharmaceuticals | Nitrosamine Impurity | 5 states |
Other Simvastatin recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |