Nitrostat Nitroglycerin Tablets Recalled Due to Temperature Abuse During Manufacturing
McKesson Medical-Surgical is recalling Nitrostat (nitroglycerin sublingual tablets) 0.4 mg due to manufacturing deviations involving temperature abuse that may affect product quality. The affected product was distributed nationwide.
What this means for you
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 involving a manufacturing quality control issue with no reported illnesses or injuries. Temperature deviations during manufacturing may affect medication quality, but this represents a precautionary recall based on process compliance rather than confirmed product harm.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Nitrostat (nitroglycerin sublingual tablets, USP) 0.4 mg distributed by Pfizer Parke-Davis. The recall affects 25-count bottles with NDC 0071-0418-13.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product during manufacturing. Temperature exposure may affect the stability and efficacy of the medication.
The affected product was distributed nationwide. Specific lot numbers could not be identified by the manufacturer; however, customers were notified with information about dates when affected product may have been shipped to them.
Patients should consult with their healthcare provider or pharmacist if they have this medication. Do not discontinue nitroglycerin therapy without consulting your healthcare provider. Contact your pharmacist to determine if you have affected product.
The recalled product
- Product
- Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
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 · cgmp deviation
See all →- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Vancomycin Injection Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09