CLASS III Drug recall · Reported 19 Nov 2014 · FDA Enforcement Report
Simvastatin Tablets, USP, 10 mg recalled by Micro Labs Usa, Inc S
Micro Labs Usa Inc S is recalling Simvastatin Tablets, USP, 10 mg, distributed in New York. The recall was initiated on 19 Aug 2014 and the FDA has classified it as Class III.
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-0246-2015
- FDA event ID
- 69268
- Recalling firm
- Micro Labs Usa Inc S, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Aug 2014
- FDA classified
- 12 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 19 Aug 2014 | Recall initiated by company | |
| 12 Nov 2014 | Classified by FDA | +85 days |
| 19 Nov 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
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
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Where it was distributed
NY
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Which lots are affected?
Lot #: STBG005, Exp 2/2015
Where was it sold?
NY
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Micro Labs Usa Inc S
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Simvastatin Tablets, USP, 80mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 20mg a) bottle (42517-0020-10) recalled | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 40mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 25 mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Other | NY |
| Drug | CLASS II | Glimepiride Tablets, USP 2 mg, a) recalled by Micro Labs Usa, Inc SGlimepiride | Micro Labs Usa Inc S | Potency & Assay | 5 states |
Other Simvastatin recalls
All 29| 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 |