CLASS II Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report
Sulfamethoxazole and Trimethoprim Tablets recalled
Aurobindo Pharma USA is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, distributed nationwide in the US. The recall was initiated on 7 Jul 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0719-2021
- FDA event ID
- 88227
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2021
- FDA classified
- 10 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 7 Jul 2021 | Recall initiated by company | |
| 10 Aug 2021 | Classified by FDA | +34 days |
| 18 Aug 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance- Potential of metal contamination.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance- Potential of metal contamination.
Which lots are affected?
Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 15 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
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|---|---|---|---|---|---|
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| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Sulfamethoxazole recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalledSulfamethoxazole And Trimethoprim | Northwind Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Sterility | Nationwide |