Fallon Wellness PAPA/PHEN/PROST Injection Recall: Lack of Sterility Assurance
Fallon Wellness recalls 1 mL vials of PAPA/PHEN/PROST injection due to lack of sterility assurance from environmental monitoring issues. Affected lots may cause infections if used.
Lower-risk recall
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Contact the company
What happened, in plain English
Fallon Wellness is recalling certain injections because they were produced during a time when environmental monitoring showed an issue, which could mean the product isn't sterile. This poses a risk of infection if the product is used. Read more at govinfonow.com/recall/42263-fallon-wellness-papa-phen-prost-injection-recall-lack-of-sterility.
Source Summary by GovInfoNow · govinfonow.com/recall/42263-fallon-wellness-papa-phen-prost-injection-recall-lack-of-sterility · Updated October 9, 2026 · FDA enforcement record: FDA #D-0174-2017
Cite this page
“Fallon Wellness PAPA/PHEN/PROST Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42263-fallon-wellness-papa-phen-prost-injection-recall-lack-of-sterility. Based on FDA recall #D-0174-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0174-2017%22&limit=1).
Why it’s dangerous
The product was made on a day when environmental monitoring data showed an excursion, meaning the manufacturing environment may not have been sterile. This could lead to contamination and infection if the injection is used.
Who’s affected
Patients who received the recalled injection vials from Fallon Wellness Pharmacy in Latham, NY, between the production date and expiration date. Those with medical conditions requiring injections are at higher risk.
How to tell if you have this one
Check for vials labeled 'PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials' from Fallon Wellness Pharmacy LLC in Latham, NY. The lot number 09202016@8 and expiration date 11/04/2016 are specific to this recall.
- Brand
Fallon Wellness- Category
Drug
All 2 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.
- Classification
Class II- Status
Terminated- Distribution
NY
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0173-2017 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.; Lot #: 09192016@41,09192016@69, Exp 11/04/2016 | 10 vials |
| D-0174-2017 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.; Lot #: 09202016@8, Exp 11/04/2016 | 5 vials |
What to do — step by step
Check Vial Details
Look for the product name, lot number 09202016@8, and expiration date 11/04/2016 on the vial label.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA terminated this recall 20 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-0174-2017 (November 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0174-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.