# FDA recall D-0264-2022

> **Lupin Pharmaceuticals Inc.** · Class III · drug recall initiated 2021-11-19.

## Product

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.

## Reason for recall

Subpotent Drug

## Distribution

nationwide within the United States

## Key facts

- **Recall number:** D-0264-2022
- **Recalling firm:** Lupin Pharmaceuticals Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-11-19
- **Report date:** 2021-12-08
- **Termination date:** 2022-11-15

- **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-0264-2022

## Citation

> AI Analytics. FDA recall D-0264-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0264-2022. Source: US FDA. Licensed CC0.

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