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.

Recall Insight

This FDA Drug action (record #D-0316-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on February 18, 2021. It is classified under Critical severity (Class I), with a current status of Terminated. Zydus Pharmaceuticals (USA) Inc is listed as the recalling firm, operating out of Pennington, NJ. Federal records indicate 1,638 packs units are affected.

The documented reason for this recall is: Crystallization: customer complaints for crystallization in finished product. Distribution data in the federal record shows the product reached: USA Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug and 1 involve the same firm, Zydus Pharmaceuticals (USA) Inc. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.