# FDA recall D-0765-2023

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2023-05-22.

## Product

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL  60015; NDC 0363-9947-35.

## Reason for recall

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

## Distribution

The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0765-2023
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2023-05-22
- **Report date:** 2023-05-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2023

## Citation

> AI Analytics. FDA recall D-0765-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0765-2023. Source: US FDA. Licensed CC0.

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