Class II · Moderate risk
Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Temperature abuse
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDC
0071-0418-13
Compare with the code on your package — it is the most precise check available.
Drug: Nitroglycerin
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 0071-0418-13
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1049-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Nitroglycerin recalls
See all
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.3MG
CGMP Deviations
Class II · Moderate risk
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton
CGMP Deviations
Class II · Moderate risk
Nitroglycerin Lingual Spray
Defective Delivery System
Class II · Moderate risk
Rectiv (nitroglycerin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Mckesson Medical-Surgical Inc. Corporate Office
All 2022 recalls
Class II · Moderate risk
Infuvite Adult
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
Medroxyprogesterone Acetate Injectable Suspension
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Class II · Moderate risk
BENLYSTA (belimumab)
CGMP Deviations; potential temperature excursions due to transit delays
Class II · Moderate risk
Evenity
CGMP Deviations; potential temperature excursions due to transit delays
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