Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported July 15, 2020
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
VistaPharm, Inc. recalled Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle… - a low-severity action.
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle… was recalled by VistaPharm, Inc. in July 15, 2020. Reason: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.. Check the official notice for the remedy. Verify recall #D-1378-2020 with the FDA Drug before acting.
The recall
VistaPharm, Inc. issued this low-severity FDA Drug recall-Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification..
- Low
- severity level
- Class III
- classification
- July 15, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1378-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1378-2020) was formally reported on July 15, 2020, with the manufacturer initiating the action on June 23, 2020. It is classified under Low severity (Class III), with a current status of Terminated. VistaPharm, Inc. is listed as the recalling firm, operating out of Largo, FL. Federal records list the affected scope as 14,760 bottles.
The documented reason for this recall is: Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification. Distribution data in the federal record shows the product reached: United States including Puerto Rico. 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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
14,760 bottles
Related Recalls
6
0 from same agency
Product description
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Reason for recall
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1378-2020 |
| Date reported | July 15, 2020 |
| Date initiated | June 23, 2020 |
| Recalling firm | VistaPharm, Inc. |
| Firm location | Largo, FL |
| Affected scope | 14,760 bottles |
| Distribution | United States including Puerto Rico |
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-1378-2020) 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? ▼
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.. Recalled by VistaPharm, Inc.. Units affected: 14,760 bottles.
Why was this product recalled? ▼
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2020. Severity: Low. Recall number: D-1378-2020.
Where was the recalled product distributed? ▼
Distribution: United States including Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1378-2020) 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.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
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 July 15, 2020. 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.