Aurobindo Pharma Recalls Olanzapine Tablets Due to Impurity Failures
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, because the product failed impurities and degradation specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 is defined as unlikely to cause adverse health consequences, aligning with the Low severity criterion for documentation or minor specification issues.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Olanzapine Tablets, USP 2.5 mg, 30-count bottles. The recall is due to the product failing impurities and degradation specifications. The affected product is manufactured for Prasco Laboratories and manufactured by Aurolife Pharma LLC.
The recall involves 13,322 bottles of the medication. The specific lot number is 561180046A1, with an expiration date of 8/2020. The product was distributed nationwide in the United States.
Consumers should check their medication for the specific NDC 66993-680-30 and lot number 561180046A1. If the product matches these details, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,322
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 #: 561180046A1
- 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
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
Same hazard · impurities
See all →- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30
Similar recalls
- ModerateAurobindo Recalls Mirtazapine Tablets Due to Manufacturing Water Leakage
FDA (Drugs) · 2020-04-22
- ModerateOlanzapine 2.5 mg Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2024-12-25
- LowDr. Reddy's Recalls Olanzapine Tablets Due to Impurity Specification Failure
FDA (Drugs) · 2017-02-15
- ModerateAurobindo Pharma Recalls Gabapentin Capsules Due to Empty Capsule Complaints
FDA (Drugs) · 2015-01-14
- ModerateSun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures
FDA (Drugs) · 2017-05-17
- LowMacleods Recalls Olanzapine Tablets Due to Impurity Levels
FDA (Drugs) · 2026-09-30