Progesterone Capsules — Class II drug recall D-0292-2021
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2021-03-10, distributed nationwide. Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability test
| Recall number | D-0292-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2021-02-26 |
| Classified | 2021-03-03 |
| Reported by FDA | 2021-03-10 |
| Terminated | 2022-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 16,449 bottles |
| Reason classes | specification failure |
| NDC | 43598-0349, 43598-0349-01, 43598-0350, 43598-0350-01 |
| Lot numbers | 1399851P1 |
| Expiration dates | 2021-02 |
Product
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.
Reason for recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
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-0292-2021. 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.