# FDA recall D-0153-2026

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2025-10-22.

## Product

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

## Reason for recall

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0153-2026
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-22
- **Report date:** 2025-11-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2026

## Citation

> AI Analytics. FDA recall D-0153-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0153-2026. Source: US FDA. Licensed CC0.

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