The Ritedose Corporation recalls Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not
Ritedose recalls Cromolyn Sodium Oral Solution (Concentrate) due to CGMP deviation. Product released before supplier approval. Not for inhalation or injection. Must be diluted before use.
Recall notice
CGMP deviation: product released prior to supplier approval.
Contact the company & request your remedy
What happened, in plain English
Ritedose is recalling Cromolyn Sodium Oral Solution (Concentrate) because it was released before supplier approval, a CGMP deviation. This means the product may not meet safety standards. The recall applies to prescription-only items sold with specific lot numbers. Read more at govinfonow.com/recall/33235-ritedose-cromolyn-sodium-oral-solution-recall-cgmp-deviation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33235-ritedose-cromolyn-sodium-oral-solution-recall-cgmp-deviation-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0946-2023
Cite this page
“Ritedose Cromolyn Sodium Oral Solution Recall: CGMP Deviation Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/33235-ritedose-cromolyn-sodium-oral-solution-recall-cgmp-deviation-risk. Based on FDA recall #D-0946-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0946-2023%22&limit=1).
Why it’s dangerous
The product was released by the manufacturer before receiving supplier approval, which is a CGMP (Current Good Manufacturing Practice) deviation. This could mean the product does not meet safety standards for oral use. However, the recall does not specify the exact risk level or potential harm.
Who’s affected
Prescription holders who have the specific lot number 23CE2 of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton. Individuals using this product for oral use only are most at risk.
How to tell if you have this one
Check for the lot number 23CE2 on the packaging. The product is a prescription-only Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL in 96 plastic ampules per carton, manufactured by The Ritedose Corporation.
- Brand
Ritedose- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number 23CE2 on the packaging to confirm if it is recalled.
Questions people ask
Is this product safe to use?
The recall states a CGMP deviation occurred, meaning the product was released before supplier approval. The official notice does not specify if it is safe to use.
What should I do if I have this product?
The recall does not provide specific action steps beyond checking the lot number. The official notice does not state a remedy for this product.
Is this product for inhalation or injection?
The product is explicitly stated as 'Not For Inhalation or Injection' and must be diluted before oral use.
Contact Ritedose
We’ve drafted a message you can send Ritedose to request your refund or repair — edit it as you like.
Subject: Recall D-0946-2023 — Ritedose Ritedose Hello, I own a Ritedose that is covered by recall D-0946-2023 from Ritedose. 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-0946-2023 (July 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0946-2023 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.