Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported April 25, 2018
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Leadiant Biosciences, INC recalled Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by H… - a low-severity action.
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by H… was recalled by Leadiant Biosciences, INC in April 25, 2018. Reason: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.. Check the official notice for the remedy. Verify recall #D-0683-2018 with the FDA Drug before acting.
The recall
Leadiant Biosciences, INC issued this low-severity FDA Drug recall-Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride..
- Low
- severity level
- Class III
- classification
- April 25, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0683-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0683-2018) was formally reported on April 25, 2018, with the manufacturer initiating the action on April 9, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Leadiant Biosciences, INC is listed as the recalling firm, operating out of Gaithersburg, MD. Federal records list the affected scope as 3,398 bottles.
The documented reason for this recall is: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. Distribution data in the federal record shows the product reached: Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,398 bottles
Related Recalls
6
5 from same agency
Product description
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01
Reason for recall
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0683-2018 |
| Date reported | April 25, 2018 |
| Date initiated | April 9, 2018 |
| Recalling firm | Leadiant Biosciences, INC |
| Firm location | Gaithersburg, MD |
| Affected scope | 3,398 bottles |
| Distribution | Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany |
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-0683-2018) 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? ▼
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01. Recalled by Leadiant Biosciences, INC. Units affected: 3,398 bottles.
Why was this product recalled? ▼
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 25, 2018. Severity: Low. Recall number: D-0683-2018.
Where was the recalled product distributed? ▼
Distribution: Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0683-2018) 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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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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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 April 25, 2018. 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.