Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported September 1, 2021
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
SigmaPharm Laboratories LLC recalled Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Ben… - a moderate-severity action.
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Ben… was recalled by SigmaPharm Laboratories LLC in September 1, 2021. Reason: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.. Check the official notice for the remedy. Verify recall #D-0766-2021 with the FDA Drug before acting.
The recall
SigmaPharm Laboratories LLC issued this moderate-severity FDA Drug recall-Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing..
- Moderate
- severity level
- Class II
- classification
- September 1, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0766-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0766-2021) was formally reported on September 1, 2021, with the manufacturer initiating the action on August 13, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. SigmaPharm Laboratories LLC is listed as the recalling firm, operating out of Bensalem, PA. Federal records list the affected scope as 1,993 bottles.
The documented reason for this recall is: Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing. Distribution data in the federal record shows the product reached: Disttibuted 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.
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 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
1,993 bottles
Related Recalls
6
0 from same agency
Product description
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Reason for recall
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0766-2021 |
| Date reported | September 1, 2021 |
| Date initiated | August 13, 2021 |
| Recalling firm | SigmaPharm Laboratories LLC |
| Firm location | Bensalem, PA |
| Affected scope | 1,993 bottles |
| Distribution | Disttibuted 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-0766-2021) 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? ▼
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4. Recalled by SigmaPharm Laboratories LLC. Units affected: 1,993 bottles.
Why was this product recalled? ▼
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0766-2021.
Where was the recalled product distributed? ▼
Distribution: Disttibuted Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0766-2021) 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
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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 September 1, 2021. 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.