Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported September 13, 2023
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ascend Laboratories, LLC recalled Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Man… - a low-severity action.
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Man… was recalled by Ascend Laboratories, LLC in September 13, 2023. Reason: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impuritie…. Check the official notice for the remedy. Verify recall #D-1145-2023 with the FDA Drug before acting.
The recall
Ascend Laboratories, LLC issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impuritie….
- Low
- severity level
- Class III
- classification
- September 13, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1145-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1145-2023) was formally reported on September 13, 2023, with the manufacturer initiating the action on July 18, 2023. It is classified under Low severity (Class III), with a current status of Terminated. Ascend Laboratories, LLC is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 99,516 sachets.
The documented reason for this recall is: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability. Distribution data in the federal record shows the product reached: The recall product was distributed 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 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
99,516 sachets
Related Recalls
6
5 from same agency
Product description
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
Reason for recall
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-1145-2023 |
| Date reported | September 13, 2023 |
| Date initiated | July 18, 2023 |
| Recalling firm | Ascend Laboratories, LLC |
| Firm location | Parsippany, NJ |
| Affected scope | 99,516 sachets |
| Distribution | The recall product was distributed 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-1145-2023) 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.
- 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? ▼
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57. Recalled by Ascend Laboratories, LLC. Units affected: 99,516 sachets.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 13, 2023. Severity: Low. Recall number: D-1145-2023.
Where was the recalled product distributed? ▼
Distribution: The recall product was distributed nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1145-2023) 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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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 September 13, 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.