Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets — Class II drug recall D-1565-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-08-07, distributed nationwide. Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed i
| Recall number | D-1565-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-07-30 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2021-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 12,938 units |
| Reason classes | specification failure |
| NDC | 68180-0903-11, 68180-0903-13 |
| Lot numbers | L800050 |
Product
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)
Reason for recall
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1565-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.