FDA Drug recall D-0316-2021
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged…
- FDA Drug
- Class I
- terminated
- Published 2021-04-07
On 2021-04-07 the FDA classified a Class I recall of Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged… by Zydus Pharmaceuticals Usa, citing crystallization: customer complaints for crystallization in finished product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0316-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-02-18 |
| Published | 2021-04-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
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
Crystallization: customer complaints for crystallization in finished product.
Identifiers
| ndc | 68382-048-01 |
|---|---|
| ndc | 68382-048-10 |
| ndc | 68382-049-01 |
| ndc | 68382-049-10 |
| code_info | Lot#: L000126, L000127, Exp 12/31/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-08-12 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa
All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0316-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.