Acyclovir Sodium Injection 500mg/10mL — Class I drug recall D-0316-2021
Terminated recall by Zydus Pharmaceuticals (USA) Inc, reported 2021-04-07, distributed nationwide. Crystallization: customer complaints for crystallization in finished product.
| Recall number | D-0316-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2021-02-18 |
| Classified | 2021-03-30 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2022-11-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,638 packages |
| NDC | 68382-0048, 68382-0048-01, 68382-0048-10, 68382-0049, 68382-0049-01, 68382-0049-10 |
| Lot numbers | L000126, L000127 |
| Expiration dates | 2021-12-31 |
Product
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
Reason for recall
Crystallization: customer complaints for crystallization in finished product.
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-0316-2021. 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.