Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported November 25, 2015
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production pract…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalled Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625… - a moderate-severity action.
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625… was recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma in November 25, 2015. Reason: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initi…. Check the official notice for the remedy. Verify recall #D-305-2016 with the FDA Drug before acting.
The recall
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma issued this moderate-severity FDA Drug recall-Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initi….
- Moderate
- severity level
- Class II
- classification
- November 25, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-305-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-305-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on September 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is listed as the recalling firm, operating out of Peoria, IL. Federal records list the affected scope as 1 dropper bottle.
The documented reason for this recall is: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility as… Distribution data in the federal record shows the product reached: Nationwide. 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, 5 from FDA Drug - 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 dropper bottle
Related Recalls
6
5 from same agency
Product description
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Reason for recall
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-305-2016 |
| Date reported | November 25, 2015 |
| Date initiated | September 3, 2015 |
| Recalling firm | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma |
| Firm location | Peoria, IL |
| Affected scope | 1 dropper bottle |
| Distribution | Nationwide |
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-305-2016) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.. Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma. Units affected: 1 dropper bottle.
Why was this product recalled? ▼
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-305-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-305-2016) 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 PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 November 25, 2015. 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.