Class II · Moderate risk
Metronidazole 500mg 100ml
Lack of sterility assurance
Is Metronidazole recalled?
Not under an active recall.
Metronidazole was recalled 15 times in the past — all now closed. Most recent: Dec 27, 2022.
Most common reason: Sterility / contamination (8 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Metronidazole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Metronidazole recalls on record
none so far in 2026; 15 on record, newest first
Class II · Moderate risk
Metronidazole tablets
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole Vaginal Gel USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Metronidazole Injection
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Class II · Moderate risk
Metronidazole 1% Gel
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Reverse Dml Lotion
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
Rosacea Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk
METRONIDazole Injection
Lack of Sterility Assurance: customer report of leaking bag
Class II · Moderate risk
Metronidazole 500mg Tablet
CGMP Deviations
Class I · High risk
Metronidazole Injection USP
Presence of Particulate Matter: identified as a cloth fiber.
Class II · Moderate risk
Metronidazole Benzoate active pharmaceutical ingredient packaged…
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 II · Moderate risk
Metronidazole Base 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 II · Moderate risk
Metronidazole Injection USP
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Class II · Moderate risk
METRONIDazole Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Metronidazole Tablets
Failed Tablet/Capsule Specifications: Some tablets had the potential to not conform to weight specifications.
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