Drug recall: Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA…

Class II FDA enforcement event 81887. Recall start date: 31 Dec 2018. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Aurobindo Pharma USA Inc. started this drug recall on 31 Dec 2018. The firm address in the FDA record is in East Windsor, NJ. FDA put the recall in Class II. FDA event 81887 has 10 product records. The first FDA enforcement report date is 23 Jan 2019. The record gives the status Ongoing.

FDA enforcement report The 10 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.

Recalling firm

Aurobindo Pharma USA Inc., East Windsor, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

10 product records in the event.

FDA event 81887: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0361-2019	Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30	18,408 bottles	Class II	Ongoing	23 Jan 2019
D-0362-2019	Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.	60,417 bottles	Class II	Ongoing	23 Jan 2019
D-0363-2019	Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.	27,688 bottles	Class II	Ongoing	23 Jan 2019
D-0364-2019	Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.	55,788 bottles	Class II	Ongoing	23 Jan 2019
D-0365-2019	Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.	23,016 bottles	Class II	Ongoing	23 Jan 2019
D-0366-2019	Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.	92,616 bottles	Class II	Ongoing	23 Jan 2019
D-0367-2019	Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.	111,239 bottles	Class II	Ongoing	23 Jan 2019
D-0368-2019	Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.	32,160 bottles	Class II	Ongoing	23 Jan 2019
D-0369-2019	Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.	53,064 bottles	Class II	Ongoing	23 Jan 2019
D-0370-2019	Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.	20,604 bottles	Class II	Ongoing	23 Jan 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class II: 60%
Product records in this event: 10Median of the firm: 1
Events of the firm on the register: 33

Other events of the firm

Other FDA enforcement events of Aurobindo Pharma USA Inc.
Initiated	Product (first record)	Type	Class	Records
23 Jul 2026	Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P	Drug	Class II	1
22 May 2025	Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,	Drug	Class II	1
6 Dec 2024	Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst	Drug	Class II	1
7 Nov 2024	Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-	Drug	Class II	3
11 Jul 2024	Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib	Drug	Class I	1
24 Apr 2024	Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND	Drug	Class II	2
2 Aug 2023	Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127	Drug	Class II	1
21 Jul 2023	Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P	Drug	Class II	2
22 May 2023	Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg	Drug	Class II	1
5 Oct 2022	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc	Drug	Class II	1

Aurobindo Pharma USA Inc.: all 33 events

Official channels

FDA enforcement report D-0361-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 81887. https://recallregister.com/fda/ii/81887/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
What quantity of product is in FDA event 81887?: The event has 10 product records. The first record gives this quantity: 18,408 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 60% of the 367 drug events that started in 2018 are in Class II.