Food, drugs, devices › Aurobindo Pharma USA Inc.
Drug recall: Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufact
FDA enforcement event 83436 is a drug recall by Aurobindo Pharma USA Inc. of East Windsor, NJ, initiated 29 Jul 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 28 Oct 2021. Initiation: voluntary: firm initiated. Aurobindo Pharma USA Inc. has 33 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aurobindo Pharma USA Inc., East Windsor, NJ.
Reason for recall
"Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B"
Distribution
"Product was distributed nationwide by three major distributors who may have further distributed the product."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1842-2019 | 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 | 2,352/1000 count bottles | Class III | Terminated | 4 Sep 2019 |
Context
Other enforcement events for Aurobindo Pharma USA Inc.
All 33 events for Aurobindo Pharma USA Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed nationwide by three major distributors who may have further distributed the product."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Oct 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.