Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
Is Acyclovir recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Acyclovir (19 total). Check the affected lots below.
Most common reason: Particulate / foreign matter (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Acyclovir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Acyclovir recalls in 2026
1 initiated in 2026, 19 in total — newest first
Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acyclovir Sodium Injection 1
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk
Acyclovir Sodium Injection 500mg/10mL
Crystallization: customer complaints for crystallization in finished product.
Class I · High risk
Acyclovir Sodium Injection 1000mg/20mL
Crystallization: customer complaints for crystallization in finished product.
Class II · Moderate risk
Acyclovir Tablets
Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
Class II · Moderate risk
Acyclovir Tablets
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Class III · Low risk
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class II · Moderate risk
Acyclovir 400mg Tablet
CGMP Deviations
Class II · Moderate risk
All acyclovir and lidocaine Products
Lack of Processing Controls
Class II · Moderate risk
Acyclovir various strengths in normal saline
Lack of sterility assurance.
Class II · Moderate risk
Acyclovir Sodium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Acyclovir Oral Suspension
Failed Stability Specification; product viscosity and or pH are below specification.
Class II · Moderate risk
Acyclovir Tablets USP 800 mg
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Class II · Moderate risk
Acyclovir
Labeling: Label Mixup: ACYCLOVIR, Tablet, 800 mg may have potentially been mislabeled as the following drug: PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 64679043304, Pedigree: AD70690_4, EXP: 5/29/2014.
Class II · Moderate risk
Acyclovir
Labeling: Label Mixup: ACYCLOVIR, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD60240_51, EXP: 5/22/2014; METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, Pedigree: W002841, EXP: 6/7/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003900, EXP: 6/27/2014; acetaZOLAMIDE
Class II · Moderate risk
Acyclovir Ophthalmic 3% Ointment 5 Gm
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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