Lower risk Drug recall · FDA · Published February 18, 2021

Zydus Acyclovir Injection Recall: Crystallization Risk

Zydus Pharmaceuticals recalls Acyclovir Sodium Injection vials due to crystallization complaints. This may affect IV infusion safety. Check NDC 68382-049-01 for affected products.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0315-2021Drug Zydus Pharmaceuticals ›

Lower-risk recall

Crystallization: customer complaints for crystallization in finished product.

Take action

Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

✎ GovInfoNow plain-language explainer

Zydus Pharmaceuticals is recalling Acyclovir Sodium Injection vials that may crystallize, potentially causing issues during intravenous infusion. This recall affects healthcare professionals using the product for IV treatments. Read more at govinfonow.com/recall/36507-zydus-acyclovir-injection-recall-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36507-zydus-acyclovir-injection-recall-crystallization-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0315-2021

Cite this page

“Zydus Acyclovir Injection Recall: Crystallization Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36507-zydus-acyclovir-injection-recall-crystallization-risk. Based on FDA recall #D-0315-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0315-2021%22&limit=1).

The FDA announced on Feb. 18, 2021, that Zydus Pharmaceuticals (USA) Inc is recalling Acyclovir Sodium Injection vials due to crystallization hazards. The recall affects 816 packs distributed nationwide.

How to tell if you have it

Brand: Zydus Pharmaceuticals
Product: Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01
Packaging: 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10
Lot codes: L000155 (Exp 12/2021), L000156 (Exp 1/2022)
Quantity: 816 packs

The hazard

The recall is due to customer complaints regarding crystallization in the finished product. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Recent brand recalls include a 2026-08-05 recall of Zydus Mirabegron 25mg Tablets for N-Nitroso Impurity Risk, a 2026-04-29 recall of Zydus Erythromycin Tablets for N-Nitroso-Desmethyl-Erythromycin Risk, and a 2026-03-09 recall of Zydus Icosapent Ethyl Capsules due to defects. Other recent recalls of similar products include Par Health Buprenorphine Injection Recall (2026-06-12), Endo USA Buprenorphine Injection Recall (2026-03-13), and Par Health Recalls Buprenorphine Injections Due to Crystallization (2026-09-08).

How to tell if you have this one

Check for vials labeled Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) with NDC 68382-049-01. The product is packaged in 10 x 20mL single-dose vials per pack NDC 68382-049-10 and requires dilution before use.

Brand
Zydus Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
USA Nationwide
NDC
68382-048-01, 68382-048-10, 68382-049-01, 68382-049-10

Recall number	Product, codes & lots	Quantity
D-0315-2021	Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.; Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022	816 packs
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 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.; Lot#: L000126, L000127, Exp 12/31/2021	1,638 packs

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for NDC 68382-049-01 on the vial label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Feb 18, 2021Firm started the recall
Mar 30, 2021FDA classified it Class I
Apr 7, 2021Published in FDA’s Enforcement Report
Nov 23, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/36507-zydus-acyclovir-injection-recall-crystallization-risk">Zydus Acyclovir Injection Recall: Crystallization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0315-2021 (February 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0315-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.