Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Risk
Walter's Pharmacy recalls 10 mL bottles of Vancomycin 25mg/mL solution due to lack of sterility assurance. Check lot numbers if you purchased in PA.
Use caution until it’s fixed
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Walter's Pharmacy is recalling Vancomycin 25mg/mL Solution in 10 mL bottles because there is a lack of assurance of sterility. This recall affects specific lots distributed in Pennsylvania. The product is prescription-only. Read more at govinfonow.com/recall/43146-walter-s-pharmacy-recalls-vancomycin-solution-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/43146-walter-s-pharmacy-recalls-vancomycin-solution-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0792-2016
Cite this page
“Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43146-walter-s-pharmacy-recalls-vancomycin-solution-due-to-sterility-risk. Based on FDA recall #D-0792-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0792-2016%22&limit=1).
Why it’s dangerous
The lack of sterility assurance means bacteria or other contaminants could be present in the solution. Using non-sterile medication can lead to serious infections, particularly when administered via injection or infusion.
Who’s affected
Patients in Pennsylvania who received Vancomycin solution from Walter's Pharmacy between the relevant dates. Individuals with compromised immune systems are at higher risk for infection if the medication is not sterile.
How to tell if you have this one
Check for Vancomycin 25mg/mL Solution in 10 mL bottles with NDC 99999-9003-78. Verify the lot numbers: 012216, 012616, 012816, 020316, or 020616. The product was distributed in Pennsylvania.
- Brand
Walter's Pharmacy- Category
Drug
All 13 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
PA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0786-2016 | Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04; Lot #: 012216, 012816, 012616, 020616 | 4 bottles |
| D-0787-2016 | Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47; Lot #: 012516, 020516 | 3 bottles |
| D-0788-2016 | Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99; Lot #: 010516, 012016 | 5 bottles |
| D-0789-2016 | Rose Bengal 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706; Lot #: 012516 | 3 bottles |
| D-0790-2016 | Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92; Lot #012516 | 1 bottle |
| D-0791-2016 | Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35; Lot #: 020316 and 011216 | 2 bottles |
| D-0792-2016 | Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78; Lot #: 012216, 012616, 012816, 020316, 020616; | 4 bottles |
| D-0793-2016 | Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09; Lot #: 112015, 112715, 113015,120515, 120715, 121215, 121515, 122115, 010516, 010716, 010816, 011116, 012016, 012816, 012916, 020316, 020416, 020516. | 22 bottles |
| D-0794-2016 | Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33; Lot #: 012116, 012516 | 2 bottles |
| D-0795-2016 | Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47; Lot #: 012116, #012516 | 1 bottle |
| D-0796-2016 | Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61; Lot #: 020216 | 5 bottles |
| D-0797-2016 | Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54; Lot #: 020216 | 1 bottle |
| D-0798-2016 | Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60; Lot #: 020216 | 1 bottle |
What to do — step by step
Contact Your Pharmacy
Call Walter's Pharmacy at 610-435-4706 to report your lot number and discuss next steps.
Do Not Use Affected Lots
Stop using any bottles with lot numbers 012216, 012616, 012816, 020316, or 020616 until you receive instructions.
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
FDA distribution: “PA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA terminated this recall 11 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.
Questions people ask
What is the specific hazard with this recall?
The hazard is a lack of assurance of sterility, meaning the medication may not be free from microbial contamination.
Where was this product sold?
The product was distributed in Pennsylvania by Walter's Pharmacy located at 401 N 17th St., Allentown, PA.
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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-0792-2016 (February 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0792-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.