medroxyPROGESTERone Acetate Injectable Suspension — Class II drug recall D-1143-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-06-22, distributed nationwide. Lack of assurance of sterility
| Recall number | D-1143-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2022-05-06 |
| Classified | 2022-06-10 |
| Reported by FDA | 2022-06-22 |
| Terminated | 2023-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 79,339 syringes |
| Reason classes | sterility |
| NDC | 50102-0591-40 |
| Lot numbers | HAC1290A, HAC2082B, JKX4312A, JKX4313A, JKX4827A |
| Expiration dates | 2022-09, 2023-06, 2023-09 |
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syringe, 150 mg/mL, Rx only, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India Distributed by: Afaxys Pharma, LLC, Charleston, SC, 29403, USA, Product of Italy, NDC 50102-591-40.
Reason for recall
Lack of assurance of sterility
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-1143-2022. 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.