Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported June 18, 2025
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Amneal Pharmaceuticals, LLC recalled Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per… - a critical-severity action.
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per… was recalled by Amneal Pharmaceuticals, LLC in June 18, 2025. Reason: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contaminati…. Check the official notice for the remedy. Verify recall #D-0488-2025 with the FDA Drug before acting.
The recall
Amneal Pharmaceuticals, LLC issued this critical-severity FDA Drug recall-Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contaminati….
- Critical
- severity level
- Class I
- classification
- June 18, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0488-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0488-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on June 2, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Amneal Pharmaceuticals, LLC is listed as the recalling firm, operating out of Bridgewater, NJ. Federal records list the affected scope as 6396 bottles.
The documented reason for this recall is: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. Distribution data in the federal record shows the product reached: 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6396 bottles
Related Recalls
6
0 from same agency
Product description
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Reason for recall
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0488-2025 |
| Date reported | June 18, 2025 |
| Date initiated | June 2, 2025 |
| Recalling firm | Amneal Pharmaceuticals, LLC |
| Firm location | Bridgewater, NJ |
| Affected scope | 6396 bottles |
| Distribution | 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-0488-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.. Recalled by Amneal Pharmaceuticals, LLC. Units affected: 6396 bottles.
Why was this product recalled? ▼
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 18, 2025. Severity: Critical. Recall number: D-0488-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0488-2025) 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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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 June 18, 2025. 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.