Aurobindo Pharma USA recalls

Aurobindo Pharma USA has 58 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 12 Aug 2026. 24 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is nitrosamine impurity.

Total recalls58since 2013

Last 12 months1reported

Class I12% of total

Ongoing24latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 4 0Jan '25 0 0 0Apr 0 1 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 1 0

Severity split

Class I 1 2%Class II 48 83%Class III 9 16%

Why aurobindo pharma usa is recalled

Product types

Brands

By year

202612%
202512%
2024712%
202347%
202247%
202147%
20201424%
20191729%
201812%
201723%

Ongoing aurobindo pharma usa recalls

24 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride	Aurobindo Pharma USA	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
25 Dec 2024Drug	CLASS II	Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 60mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide

All aurobindo pharma usa recalls, newest first

58 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride	Aurobindo Pharma USA	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
25 Dec 2024Drug	CLASS II	Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Cinacalcet Tablets, 60mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
28 Aug 2024Drug	CLASS I	Healthy Living Acetaminophen, Aspirin (Nsaid) and Caffeine recalledAcetaminophen Aspirin And Caffeine	Aurobindo Pharma USA	Labeling Errors	NJ, NY, PA
15 May 2024Drug	CLASS II	Clorazepate Dipotassium Tablets, USP, 75 mg, a) recalledClorazepate Dipotassium	Aurobindo Pharma USA	Other	Nationwide
15 May 2024Drug	CLASS II	Clorazepate Dipotassium Tablets, USP, 5 mg, a) recalledClorazepate Dipotassium	Aurobindo Pharma USA	Other	Nationwide
27 Sep 2023Drug	CLASS II	Rasagiline Tablets 5mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.