Aurobindo Pharma USA recalls

Aurobindo Pharma USA has 59 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 recalls59since 2013

Last 12 months1reported

Class I23% of total

Ongoing24latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 4 0 0Feb 0 0 0May 1 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 2 3%Class II 48 81%Class III 9 15%

Why aurobindo pharma usa is recalled

Product types

Brands

By year

202612%
202512%
2024712%
202347%
202247%
202147%
20201424%
20191831%
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

59 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, 3.75 mg, a) recalledClorazepate Dipotassium	Aurobindo Pharma USA	Other	Nationwide
15 May 2024Drug	CLASS II	Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) recalledClorazepate Dipotassium	Aurobindo Pharma USA	Other	Nationwide
27 Sep 2023Drug	CLASS II	Rasagiline Tablets 0.5mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
30 Aug 2023Drug	CLASS II	Rufinamide Tablets, USP 200 mg recalled by Aurobindo Pharma USARufinamide	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
30 Aug 2023Drug	CLASS II	Rufinamide Tablets, USP 400 mg recalled by Aurobindo Pharma USARufinamide	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
31 May 2023Drug	CLASS II	Pain Reliever, Acetaminophen USP Caplets, 500 mg recalledPain Reliever	Aurobindo Pharma USA	Potency & Assay	Nationwide
2 Nov 2022Drug	CLASS II	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg recalledQuinapril Hydrochloride/hydrochlorothiazide	Aurobindo Pharma USA	Nitrosamine Impurity	Nationwide
20 Apr 2022Drug	CLASS III	Cyanocobalamin Injection, USP, 1,000 mcg per mL recalledCyanocobalamin	Aurobindo Pharma USA	Potency & Assay	Nationwide
23 Feb 2022Drug	CLASS II	Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, Sterile recalled	Aurobindo Pharma USA	Potency & Assay	Nationwide
2 Feb 2022Drug	CLASS II	Pioglitazone Tablets USP, 45 mg recalled by Aurobindo Pharma USAPioglitazone	Aurobindo Pharma USA	Potency & Assay	Nationwide
1 Dec 2021Drug	CLASS III	Carvedilol Tablets, USP, 6.25 mg recalled by Aurobindo Pharma USACarvedilol	Aurobindo Pharma USA	Potency & Assay	Nationwide
29 Sep 2021Drug	CLASS II	Metoprolol Tartrate Tablets USP 100 mg recalled by Aurobindo Pharma USAMetoprolol Tartrate	Aurobindo Pharma USA	Foreign Material	Nationwide
18 Aug 2021Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Aurobindo Pharma USA	Foreign Material	Nationwide
10 Mar 2021Drug	CLASS II	Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine	Aurobindo Pharma USA	Other	4 states
11 Nov 2020Drug	CLASS III	Fluent Children's Fever + Pain Ibuprofen Oral Suspension recalledChildrens Ibuprofen	Aurobindo Pharma USA	Other	NJ
2 Sep 2020Drug	CLASS II	Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim	Aurobindo Pharma USA	Foreign Material	Nationwide
1 Jul 2020Drug	CLASS II	Clozapine Tablets USP tablet, 100mg recalled by Aurobindo Pharma USAClozapine	Aurobindo Pharma USA	Other	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
22 Apr 2020Drug	CLASS II	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg recalledAcetaminophen And Codeine Phosphate	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020Drug	CLASS II	Simvastatin Tablets, USP 40mg recalled by Aurobindo Pharma USASimvastatin	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020Drug	CLASS II	Mirtazapine Tablets, USP 15mg recalled by Aurobindo Pharma USAMirtazapine	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020Drug	CLASS II	Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg recalledOxycodone And Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	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.