Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, M… recall
FDA recall D-0635-2026 · initiated Jun 2, 2026
Dabur India Limited recalled Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… in Jun 2026 — an FDA Class II recall (D-0635-2026) because CGMP Deviations; deficiencies observed during FDA inspection.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; deficiencies observed during FDA inspection
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1087 tubes
Details
- Product
- Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
- Recalling company
- Dabur India Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jun 2, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… recalled?
- Dabur India Limited recalled Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… in Jun 2026 — an FDA Class II recall (D-0635-2026) because CGMP Deviations; deficiencies observed during FDA inspection. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… recalled?
- Per the FDA enforcement record, the reason for recall D-0635-2026 was: CGMP Deviations; deficiencies observed during FDA inspection
- Is a recalled Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 co… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot# 007, 008, 009, 015, 016, Within Expiry.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0635-2026.