Acyclovir Sodium Injectable Recalled for Particulate Matter
AuroMedics Pharma is recalling Acyclovir Sodium injection due to dark red, brown, and black particulate matter found in vials. Approximately 89,400 vials were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves particulate contamination in an injectable medication, which constitutes a risk-of-harm product. Although no illnesses or injuries have been reported, the presence of particulate matter in an intravenous injection poses potential risk to patients if administered.
Plain-English summary
AuroMedics Pharma LLC is recalling Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), distributed nationwide. The recall was initiated following customer complaints of dark red, brown, and black particulate matter floating inside vials.
The affected product is Lot AC22006 with an expiration date of 08/2023. Approximately 89,400 vials of the 10 mL single-dose vials were distributed throughout the USA. The product is manufactured in India and distributed by AuroMedics Pharma LLC in E. Windsor, New Jersey.
Patients and healthcare providers should immediately discontinue use of affected vials from this lot. Individuals who have received an injection from an affected vial should contact their healthcare provider for medical evaluation and guidance on alternative acyclovir products or treatment options.
The recalled product
- Product
- ACYCLOVIR SODIUM (ACYCLOVIR SODIUM)
- Brand
- ACYCLOVIR SODIUM
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injectable / Intravenous
- Hazard
- Affected units
- 89,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: AC22006
- Exp 08/2023
UPCs (2)
- 0355150155200
- 0355150154104
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ACYCLOVIR SODIUM
- HighInjectable Acyclovir Sodium Recalled for Particulate Matter Contamination
FDA (Drugs) · 2023-01-11
Same manufacturer · AuroMedics Pharma LLC
See all →- HighFondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
FDA (Drugs) · 2022-11-02
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SeverePolymyxin B for Injection Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2022-02-16
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
- ModerateAuroMedics Recalls Glycopyrrolate Injection Due to Benzaldehyde Impurity
FDA (Drugs) · 2020-02-26
Same hazard · particulate matter
See all →- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- HighInjectable Acyclovir Sodium Recalled for Particulate Matter Contamination
FDA (Drugs) · 2023-01-11
- SevereZydus Recalls Acyclovir Sodium Injection Due to Crystallization
FDA (Drugs) · 2021-04-07
- LowAuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter
FDA (Drugs) · 2019-12-04
- CriticalAuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate
FDA (Drugs) · 2018-02-14
- SevereAuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter
FDA (Drugs) · 2018-05-16
- LowAurobindo Recalls Discolored Pantoprazole Sodium Injection Vials
FDA (Drugs) · 2017-02-15