VistaPharm, Inc. is recalling Hydrocodone Bitartrate & Acetaminophen Oral Solution because testing showed it exceeded specifications for impurities or degradation products at the three-month stability mark. This issue affects specific lots of both 15 mL unit dose cups and 473 mL bottles distributed nationwide. The recall record does not specify a remedy or current instructions for consumers. Read more at govinfonow.com/recall/48680-vistapharm-inc-recalls-hydrocodone-bitartrate-acetaminophen-oral-solution-7-5.
“VistaPharm Hydrocodone Recall: Impurity Risk.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48680-vistapharm-inc-recalls-hydrocodone-bitartrate-acetaminophen-oral-solution-7-5. Based on FDA recall #D-1416-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1416-2012%22&limit=1).
VistaPharm, Inc. voluntarily recalled Hydrocodone Bitartrate & Acetaminophen Oral Solution on May 30, 2012, after testing showed impurities exceeded specifications, the FDA said. The recall affects specific lots distributed nationwide.
How to tell if you have it
Brand: VistaPharm
Product: Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Forms: 15 mL Unit Dose Cups (NDC 66689-023-50) and 473 mL Bottles (NDC 66689-023-16)
Lot Codes: 251400 and 251500
Expiration Dates: 07/13
The hazard
The product failed to meet specifications for impurities or degradation products during three-month stability testing, according to the FDA recall record.
Context
GovInfoNow's records show VistaPharm, Inc. has 19 other recalls on file since January 19, 2011. Other recent recalls of similar products include VistaPharm Pyridostigmine Bromide Oral Solution (September 30, 2022), VistaPharm Clobazam Oral Suspension (January 7, 2022), and VistaPharm NYSTATIN Oral Suspension (September 25, 2020). Other recent recalls of similar products include Hikma Ramipril Capsules (August 24, 2026), Sun Pharmaceutical Fluocinolone Acetonide Solution (December 30, 2025), and Novadoz Glycopyrrolate Oral Solution (December 15, 2025).
How to tell if you have this one
Check if you have Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL manufactured by VistaPharm in Largo, FL. Look for NDC numbers 66689-023-50 (15 mL Unit Dose Cups) or 66689-023-16 (473 mL Bottles). Affected lots are 251400 and 251500, both with an expiration date of 07/13.
Brand
VistaPharm
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your Hydrocodone Bitartrate & Acetaminophen Oral Solution matches the recalled NDC numbers and lot numbers listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the affected product and what steps they recommend for replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1416-2012 (May 30, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1416-2012 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.