Aurobindo Recalls Olanzapine Tablets Due to Failed Impurity Specifications
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, because the product failed impurity and degradation specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 7.5 mg, 30-count bottles. The recall involves 7,547 bottles of the prescription medication, identified by Lot # 563180012A1 and an expiration date of 8/2020. The product was manufactured for Prasco Laboratories and manufactured by Aurolife Pharma LLC.
The recall was initiated because the product failed impurity and degradation specifications. The agency has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide in the U.S.A. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,547
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 563180012A1
- Exp 8/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17