medroxyPROGESTERone Acetate Injectable Suspension — Class II drug recall D-1147-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-06-22, distributed nationwide. Lack of assurance of sterility
| Recall number | D-1147-2022 |
|---|---|
| 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 | 26,892 vials |
| Reason classes | sterility |
| NDC | 16714-0090-40 |
| Lot numbers | HAC0163B, HAC1741A, HAC2074A |
| Expiration dates | 2023-01, 2023-04, 2023-06 |
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-090-40 packaged in 25 count carton.
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-1147-2022. 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.