Severity
Critical
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.
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 FDA Drug action (record #D-0488-2023) was formally reported on March 29, 2023, with the manufacturer initiating the action on February 24, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Global Pharma Healthcare Private Limited is listed as the recalling firm, operating out of Chennai, N/A. Federal records list the affected scope as 50,000 tubes.
The documented reason for this recall is: Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. Distribution data in the federal record shows the product reached: Product was imported by one distributor, Delsam Pharma, LLC, who further distributed the product via internet sales Nationwide in the USA.. Distribution scope 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 - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
50,000 tubes
Related Recalls
6
0 from same agency
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
| 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0488-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with Blue Bull Extreme Male Enhancement Supplement, total of 15 … →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 29, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.