FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is for a manufacturing process deviation (temperature abuse) detected proactively without confirmed health impact, consistent with a precautionary recall.
Plain-English summary
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% (NDC 0781-7077-87) distributed by McKesson Medical-Surgical Inc. The recall was initiated due to a current Good Manufacturing Practice (cGMP) deviation involving temperature abuse of the product during manufacturing.
This is a prescription medication used to treat bacterial infections. Seven tubes of the affected product were distributed nationwide in the United States. McKesson Medical-Surgical Inc. was unable to identify specific lot numbers in individual shipments to determine the exact units affected at each location.
Patients currently using this product should consult their healthcare provider or pharmacist regarding their medication. Do not stop taking the medication without first speaking with a healthcare professional. Individuals who have already used the recalled product and have questions or concerns should contact their pharmacist or physician.
The recalled product
- Product
- Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Vaginal
- Affected units
- 7
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateFluocinonide Gel Recalled for Manufacturing Process Deviations
FDA (Drugs) · 2022-03-30
- ModerateSafecor Health Recalls Metronidazole Tablets Due to CGMP Deviations
FDA (Drugs) · 2017-06-21
- SevereBaxter Recalls Metronidazole Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-07-10
- ModerateCardinal Health Recalls Miconazole 7 Cream Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- LowAbbVie Recalls AndroGel Testosterone Gel Due to Temperature Abuse
FDA (Drugs) · 2017-11-01