Key facts
| Recalling firm | Dabur India Limited |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. |
| Classification | Class II |
| Recall number | D-0640-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | CGMP Deviations; deficiencies observed during FDA inspection |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Dabur India Limited and the affected product is described in FDA's record as: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.. FDA's stated reason for the recall is: CGMP Deviations; deficiencies observed during FDA inspection. The recall is tracked under FDA recall number D-0640-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. -- and the recall number D-0640-2026. If it matches, stop using or distributing it and contact Dabur India Limited or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
Dabur India Limited’s FDA history
Argus HQ has recorded 15 total FDA actions tied to Dabur India Limited: 0 warning letters, 14 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What was recalled and why?
- Dabur India Limited recalled Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.. FDA's record states the reason for recall as: CGMP Deviations; deficiencies observed during FDA inspection. The recall is logged under FDA recall number D-0640-2026 with a Class II classification.
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.) and recall number D-0640-2026, then follow Dabur India Limited's recall instructions.
- Has Dabur India Limited had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 15 total FDA actions tied to Dabur India Limited, including 14 recalls and 0 warning letters.
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Related enforcement actions
Full FDA history for Dabur India LimitedCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1… by Dabur India Limited — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-dabur-india-limited-d-0640-2026
"FDA Class II Recall: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1… by Dabur India Limited — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-dabur-india-limited-d-0640-2026.
Argus HQ Research. "FDA Class II Recall: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1… by Dabur India Limited — Recall Details." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/fda-recall-dabur-india-limited-d-0640-2026.
@misc{argushq_argushq_ai_recall_fda_recall_dabur_india_limited_d_0640_2026_2026,
title = {FDA Class II Recall: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1… by Dabur India Limited — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-dabur-india-limited-d-0640-2026},
note = {Accessed: July 24, 2026}
}Source: FDA.gov — Recalls ↗

