Qualitest Hydrocortisone Lotion Recall: Superpotent Drug Risk
Qualitest Pharmaceuticals recalls hydrocortisone lotion with high potency levels. This may cause excessive skin reactions. Check lot numbers and contact for details.
Lower-risk recall
Superpotent Drug: above specification for the assay.
Contact the company
What happened, in plain English
Qualitest Pharmaceuticals is recalling hydrocortisone lotion that may be too strong. Using this product could cause skin irritation or other reactions. People with skin conditions should be especially cautious. Read more at govinfonow.com/recall/41631-qualitest-hydrocortisone-lotion-recall-superpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41631-qualitest-hydrocortisone-lotion-recall-superpotent-drug-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0859-2017
Cite this page
“Qualitest Hydrocortisone Lotion Recall: Superpotent Drug Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41631-qualitest-hydrocortisone-lotion-recall-superpotent-drug-risk. Based on FDA recall #D-0859-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0859-2017%22&limit=1).
Why it’s dangerous
The hydrocortisone lotion contains more active ingredient than specified. This can lead to stronger skin reactions like redness, itching, or irritation. The risk is higher for people with sensitive skin or existing skin conditions.
Who’s affected
People who have the recalled hydrocortisone lotion for skin conditions. Those with sensitive skin or existing skin issues are at higher risk.
How to tell if you have this one
Check the product label for the lot numbers: 0000004961 (exp. 05/17), 0000005197-0000005199 (exp. 07/17), 0000005201-0000005204 (exp. 09/17), 0000005200, 0000007998-0000007999, 0000007022 (exp. 12/17), 0000009176 (exp. 04/18), 0000012281-0000012282 (exp. 12/18).
- Brand
Qualitest Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers listed above on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico.” 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.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0859-2017 (May 8, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0859-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.