Food, drugs, devices › Aurobindo Pharma Ltd.
Drug recall: Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2
Aurobindo Pharma Ltd. (East Windsor, NJ) initiated this drug recall on 2 Feb 2018; FDA lists 1 product record under event 79119, classified Class III.
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. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 18 Feb 2021. Initiation: voluntary: firm initiated. Aurobindo Pharma Ltd. has 3 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 Ltd., East Windsor, NJ.
Reason for recall
"Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg"
Distribution
"Nationwide within the US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0427-2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05. | 7476 bottles | Class III | Terminated | 28 Feb 2018 |
Context
Other enforcement events for Aurobindo Pharma Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Jan 2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by | Drug | Class I | 1 |
| 9 Mar 2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aur | Drug | Class II | 1 |
All 3 events for Aurobindo Pharma Ltd.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg"
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: "Nationwide within the US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Feb 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.