PlainRecalls
CriticalClass IOngoing

FDA Drug recall · Reported March 29, 2023

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Recall #
D-0488-2023
Affected scope
50,000 tubes
Initiated
February 24, 2023
Verify with FDA Drug →
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Global Pharma Healthcare Private Limited recalled Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 gram… - a critical-severity action.

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 gram… was recalled by Global Pharma Healthcare Private Limited in March 29, 2023. Reason: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.. Check the official notice for the remedy. Verify recall #D-0488-2023 with the FDA Drug before acting.

The recall

Global Pharma Healthcare Private Limited issued this critical-severity FDA Drug recall-Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria..

Critical
severity level
Class I
classification
March 29, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0488-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Dietary Supplements recalls over time

Where this recall sits in its category - 2,014 dietary supplements recalls on record

0100200300400 20072010201320162019202220252026 21
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.

Reason for recall

Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Ongoing
Recall number D-0488-2023
Date reported March 29, 2023
Date initiated February 24, 2023
Recalling firm Global Pharma Healthcare Private Limited
Firm location Chennai, N/A
Affected scope 50,000 tubes
Distribution Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0488-2023) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.. Recalled by Global Pharma Healthcare Private Limited. Units affected: 50,000 tubes.
Why was this product recalled?
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 29, 2023. Severity: Critical. Recall number: D-0488-2023.
Where was the recalled product distributed?
Distribution: Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar Dietary Supplements · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Compare this recall with Goody King Magnetic Building Cubes and Blocks Recalled Due … → · All Dietary Supplements recalls

This recall: FDA Drug, reported March 29, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026