Recall Record: Class II Recall: Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc… by Dabur India Limited

Key facts

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 -- Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC (additional items listed in FDA's full record) -- and the recall number D-0632-2026. 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.

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: Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC (additional items listed in FDA's full record). FDA's stated reason for the recall is: CGMP Deviations; deficiencies observed during FDA inspection. The recall is tracked under FDA recall number D-0632-2026 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.

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 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 (Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC (additional items.

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.

What is the FDA recall number for this event?

FDA recall number D-0632-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions