Advanced Pharma NitroGlycerin Recall: Stability Issues May Affect Safety
Advanced Pharma recalls NitroGlycerin injections due to stability concerns that could affect safety. Products with specific lot numbers and expiration dates are affected. Consumers should check their product details and contact the manufacturer for guidance.
Lower-risk recall
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Contact the company
What happened, in plain English
Advanced Pharma is recalling NitroGlycerin injections because some batches don't have stable chemical properties over time. This could lead to unsafe concentrations of the medication if used after the expiration date. Read more at govinfonow.com/recall/41567-advanced-pharma-nitroglycerin-recall-stability-issues-may-affect-safety.
Source Summary by GovInfoNow · govinfonow.com/recall/41567-advanced-pharma-nitroglycerin-recall-stability-issues-may-affect-safety · Updated October 8, 2026 · FDA enforcement record: FDA #D-0119-2018
Cite this page
“Advanced Pharma NitroGlycerin Recall: Stability Issues May Affect Safety.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41567-advanced-pharma-nitroglycerin-recall-stability-issues-may-affect-safety. Based on FDA recall #D-0119-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0119-2018%22&limit=1).
Why it’s dangerous
The medication's stability data does not support the expiration dates on the packaging. This means the drug may degrade over time, potentially leading to unsafe concentrations when administered.
Who’s affected
People who have the specific NitroGlycerin injection products with the listed lot numbers and expiration dates. Patients using these medications for medical purposes are most at risk.
How to tell if you have this one
Check for the lot numbers and expiration dates listed in the recall notice: 4/20/17 0307 265-86361S, BUD 6/19/17 and other specific batch codes. The product is a prescription-only injection sold in boxes of 25 syringes.
- Brand
Advanced Pharma- Category
Drug
All 7 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide in the USA to hospitals and medical facilities.
| Recall number | Product, codes & lots | Quantity | Class |
|---|---|---|---|
| D-0113-2018 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.; Lot: 4/17/17 0857 81861S, BUD 08/15/2017 | 550 syringes | Class I |
| D-0114-2018 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.; Lot: 4/10/17 1441 257-86367S, BUD 6/9/17; 4/17/17 0950 86367S, BUD¿6/16/2017; 4/20/17 1505 257-86367S, BUD 6/19/2017; 4/24/17 0115 15-86367S, BUD ¿6/23/2017; 4/26/17 0301 387-86367S, BUD 6/25/2017 | 320 syringes | Class I |
| D-0115-2018 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.; Lot: 4/19/17 1445 248-86361S, BUD¿6/18/2017 | 50 syringes | Class I |
| D-0116-2018 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61.; Lot: 3/3/17 1830 81861S, BUD 07/01/17; 3/27/17 0658 81861S, BUD 7/25/17 | 4800 syringes | Class II |
| D-0117-2018 | NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj, USP (2 mg per 20 mL) 20 mL Sterile single dose syringe, packaged in 10 x 5 (FIFTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-62.; Lot: 5/31/17 0202 5-81862S, BUD 7/30/17 | 50 syringes | Class II |
| D-0118-2018 | NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packaged in 8 x 5 (FORTY) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-67.; Lot: 4/26/17 0730 20-86367S, BUD 6/25/17; 4/24/17 0106 241-86367S, BUD 6/23/17; 5/1/17 1500 45-86367S, BUD 6/30/17; 5/9/17 1103 241-86367S, BUD 7/8/17; 5/9/17 1104 257-86367S, BUD 7/8/17; 5/12/17 0839 15-86367S, BUD 7/11/17; 5/19/17 0109 15-86367S, BUD 7/18/17; 5/22/17 0828 387-86367S, BUD 7/21/17; 5/23/17 0721 257-86367S, BUD 7/22/17; 5/24/17 0200 241-86367S, BUD 7/23/17; 5/24/17 0203 20-86367S, BUD 7/23/17; 5/26/17 0315 15-86367S, BUD 7/25/17; 5/31/17 1217 20-86367S, BUD 7/30/17 | 680 syringes | Class II |
| D-0119-2018 | NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-863-61.; Lot: 4/20/17 0307 265-86361S, BUD 6/19/17; 4/26/17 0732 265-86361S, BUD 6/25/17; 4/28/17 0215 265-86361S, BUD 6/27/17; 5/2/17 0310 248-86361S, BUD 7/1/17; 5/4/17 1422 248-86361S, BUD 7/3/17; 5/12/17 0841 248-86361S, BUD 7/11/17; 5/18/17 0206 250-86361S, BUD 7/17/17 | 550 syringes | Class II |
What to do — step by step
Check Product Details
Look for the lot numbers and expiration dates on the packaging to determine if your product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA to hospitals and medical facilities.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0119-2018 (June 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0119-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.