# FDA recall D-1081-2023

> **Lupin Pharmaceuticals Inc.** · Class I · drug recall initiated 2023-06-23.

## Product

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

## Reason for recall

Failed Stability Specification and Failed Impurities/Degradation Specifications:  out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

## Distribution

USA nationwide.

## Key facts

- **Recall number:** D-1081-2023
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-06-23
- **Report date:** 2023-08-09
- **Termination date:** 2025-01-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Baltimore, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1081-2023

## Citation

> AI Analytics. FDA recall D-1081-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-1081-2023. Source: US FDA. Licensed CC0.

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