CLASS III Drug recall · Reported 4 Sep 2019 · FDA Enforcement Report
Simvastatin Tablets, USP 40 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Simvastatin Tablets, USP 40 mg, distributed nationwide in the US. The recall was initiated on 29 Jul 2019 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-1842-2019
- FDA event ID
- 83436
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Simvastatin
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jul 2019
- FDA classified
- 26 Aug 2019
- Reported
- 4 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cholesterol Medication
Timeline
| 29 Jul 2019 | Recall initiated by company | |
| 26 Aug 2019 | Classified by FDA | +28 days |
| 4 Sep 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Product as listed by the FDA
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Where it was distributed
Product was distributed nationwide by three major distributors who may have further distributed the product.
Questions about this recall
Is Simvastatin Tablets, USP 40 mg recalled?
Yes. Aurobindo Pharma USA recalled Simvastatin Tablets, USP 40 mg on 29 Jul 2019. The recall is Class III and its status is Terminated. Recall number D-1842-2019.
Why was it recalled?
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Which lots are affected?
05318054B, exp 3/2021
Where was it sold?
Product was distributed nationwide by three major distributors who may have further distributed the product.
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 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.
More recalls from Aurobindo Pharma USA
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
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 |