CLASS II Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalled
Golden State Medical Supply is recalling Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b), distributed in Arizona, Missouri. The recall was initiated on 14 Oct 2021 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-0227-2022
- FDA event ID
- 88866
- Recalling firm
- Golden State Medical Supply, Camarillo, CA
- Manufacturer
- Golden State Medical Supply, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Oct 2021
- FDA classified
- 9 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 14 Oct 2021 | Recall initiated by company | |
| 9 Nov 2021 | Classified by FDA | +26 days |
| 17 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Where it was distributed
Distributed to two distributors located in AZ and MO
Questions about this recall
Is Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) recalled?
Yes. Golden State Medical Supply recalled Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a), b) on 14 Oct 2021. The recall is Class II and its status is Terminated. Recall number D-0227-2022.
Why was it recalled?
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Which lots are affected?
a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Where was it sold?
Distributed to two distributors located in AZ and MO
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 | Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel | Golden State Medical Supply | Potency & Assay | Nationwide |
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| Drug | CLASS III | Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone | Golden State Medical Supply | Other | Nationwide |
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Other Ezetimibe recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Ezetimibe and Simvastatin Tablets, 10mg/40mg recalledEzetimibe And Simvastatin | Glenmark Pharmaceuticals Inc., U | Potency & Assay | Nationwide |
| Drug | CLASS II | Ezetimibe and Simvastatin Tablets, 10 mg/80mg recalledEzetimibe And Simvastatin | Golden State Medical Supply | Potency & Assay | AZ, MO |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) recalledEzetimibe And Simvastatin | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |