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Drug recall · FDA · Published September 3, 2019

Compounded Solutions in Pharmacy recalls 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles

Recall of 10% Acetyl-L-Cysteine Ophthalmic Solutions in 5ml, 10ml, and 15ml dropper bottles due to lack of processing controls. Affected lots with specific expiration dates.

🇺🇸 FDA recall #D-1854-2019DrugCompounded Solutions in Pharmacy ›
Take action

Contact the company & request your remedy

Recalling firmCompounded Solutions in Pharmacy810 Main St · Monroe, CT 06468-2809
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Compounded Solutions in Pharmacy is recalling 10% Acetyl-L-Cysteine Ophthalmic Solutions in 5ml, 10ml, and 15ml dropper bottles. The recall is due to a lack of processing controls that could affect product safety. Read more at govinfonow.com/recall/38034-compounded-solutions-10-acetyl-l-cysteine-eye-drops-recall-processing.

Source Summary by GovInfoNow · govinfonow.com/recall/38034-compounded-solutions-10-acetyl-l-cysteine-eye-drops-recall-processing · Updated October 5, 2026 · FDA enforcement record: FDA #D-1854-2019

Cite this page

“Compounded Solutions 10% Acetyl-L-Cysteine Eye Drops Recall: Processing Control Issue.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38034-compounded-solutions-10-acetyl-l-cysteine-eye-drops-recall-processing. Based on FDA recall #D-1854-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1854-2019%22&limit=1).

Why it’s dangerous

The recall states there was a lack of processing controls, which could lead to product safety issues. However, the exact hazard mechanism is not clearly described in the notice.

Who’s affected

People who have purchased or used these eye drops from Compounded Solutions in Pharmacy. Those who have the specific lots listed with expiration dates are most at risk.

How to tell if you have this one

Check for 10% Acetyl-L-Cysteine Ophthalmic Solutions in 5ml, 10ml, or 15ml dropper bottles. Look for the lot numbers and expiration dates listed in the recall notice.

  • Brand
    Compounded Solutions in Pharmacy
  • Category
    Drug
FDA recall event · 3 products

All 3 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
    Product was dispensed to patients
Recall numberProduct, codes & lotsQuantity
D-1853-201920% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.; Lots: 07172019@39 exp: 8/31/19, Rx # 215042 06192019@28 exp: 7/03/19, Rx # 219335 06052019@8 exp: 6/19/19; Rx # 2228263x3 ml dropper bottles
D-1854-201910% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles; Lots: a) 08012019@33 exp: 8/15/19, 07182019@66 exp: 8/01/19, 07182019@15 exp: 8/01/19, 07012019@46 exp. 08/31/19, 07082019@27 exp: 8/31/19, b) 07082019@55 exp: 8/31/19; 07182019@55 exp: 08/31/19; 06242019@55 exp: 8/31/19; 06202019@16 exp: 8/31/19 c) 08052019@11 exp: 11/3/19a) 6x5ml b) 4x10 c) 1x15 ml bottles,
D-1855-20195% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles; Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19a) 4x5 ml, b) 1x10 ml bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the lot number and expiration date on the bottle to see if it matches the affected lots listed in the recall.

✎ GovInfoNow

Questions people ask

What is the specific hazard with these eye drops?

The recall mentions a lack of processing controls, but does not specify the exact hazard mechanism.

Which lots are affected?

Affected lots include specific combinations of lot numbers and expiration dates listed in the recall notice.

Do I need to stop using these eye drops immediately?

The recall does not provide a remedy or specific instructions to stop using the product immediately.

Take action

Contact Compounded Solutions in Pharmacy

We’ve drafted a message you can send Compounded Solutions in Pharmacy to request your refund or repair — edit it as you like.

Subject: Recall D-1854-2019 — Compounded Solutions in Pharmacy Compounded Solutions in Pharmacy

Hello,

I own a Compounded Solutions in Pharmacy that is covered by recall D-1854-2019 from Compounded Solutions in Pharmacy.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1854-2019 (September 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1854-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA