Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories,
Crown Laboratories recalls Nystatin Cream, USP 100,000 units per gram, 30 grams (Rx Only) due to subpotent drug levels. This may not treat infections effectively.
Lower-risk recall
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Contact the company & request your remedy
What happened, in plain English
Crown Laboratories is recalling Nystatin Cream, USP 30 grams (Rx Only) because it was found to have lower-than-stated drug levels. This means the cream might not work as intended for infections. Read more at govinfonow.com/recall/37057-crown-laboratories-nystatin-cream-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37057-crown-laboratories-nystatin-cream-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1338-2020
Cite this page
“Crown Laboratories Nystatin Cream Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37057-crown-laboratories-nystatin-cream-recall-subpotent-drug-risk. Based on FDA recall #D-1338-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1338-2020%22&limit=1).
Why it’s dangerous
The cream was tested at 9 months and found to have lower-than-stated Nystatin levels. This means it may not be strong enough to treat fungal infections effectively.
Who’s affected
Prescription users of Nystatin Cream, USP 30 grams (Rx Only) manufactured by Crown Laboratories. People with fungal infections are most at risk if the cream doesn't work properly.
How to tell if you have this one
Check for Nystatin Cream, USP 30 grams (Rx Only) with NDC 0316-0221-30, manufactured by Crown Laboratories, Inc. in Johnson City, TN. The lot number Y0378A expires July 2021.
- Brand
Crown Laboratories- 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
Distributed Nationwide in the USA.- NDC
0316-0221-15, 0316-0221-30
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1338-2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30; Lot: Y0378A, EXP 07/2021 | 62,274 tubes |
| D-1339-2020 | Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15; Lot: Y0378, EXP 07/2021 | 35,931 tubes |
What to do — step by step
Check Product Details
Look for Nystatin Cream, USP 30 grams (Rx Only) with NDC 0316-0221-30, manufactured by Crown Laboratories, Inc. in Johnson City, TN.
Questions people ask
Is this cream safe to use?
The cream may not work as intended due to lower-than-stated drug levels, so it's not recommended for use.
What should I do if I have this cream?
The official recall does not specify a remedy, so contact Crown Laboratories for guidance.
How can I tell if I have the recalled product?
Check for Nystatin Cream, USP 30 grams (Rx Only) with NDC 0316-0221-30, manufactured by Crown Laboratories, Inc. in Johnson City, TN, and lot number Y0378A (expires July 2021).
Contact Crown Laboratories
We’ve drafted a message you can send Crown Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-1338-2020 — Crown Laboratories Crown Laboratories Hello, I own a Crown Laboratories that is covered by recall D-1338-2020 from Crown Laboratories. 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-1338-2020 (June 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1338-2020 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.