Recall Register

Food, drugs, devices › Firms

Aurobindo Pharma Ltd.

FDA recalling firm · 3 enforcement events · 3 product records · 2012–2018 · N/A, NJ

Aurobindo Pharma Ltd. has 3 FDA enforcement events on this register (3 product records) between 2012 and 2018: 3 drug; the busiest year was 2018 with 2.

33% of its events are Class I; the most common class is Class I (1). 0 events are listed as ongoing; the recalling firm's address is in N/A and NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
2 Feb 2018Metformin 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.DrugClass III1Terminated
2 Jan 2018Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20DrugClass I1Terminated
9 Mar 2012Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, IndiaDrugClass II1Terminated

By type and class

Drug3
Class I1
Class II1
Class III1

Class I: 33% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Aurobindo Pharma Ltd. by year initiated.

Questions and answers

How many FDA recalls has Aurobindo Pharma Ltd. had?

3 enforcement events (3 product records) on this register, 2012–2018: 3 drug.

Are any Aurobindo Pharma Ltd. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Aurobindo Pharma Ltd. recalls?

1 Class I, 1 Class II, 1 Class III. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.