CLASS II Drug recall · Reported 15 Jun 2022 · FDA Enforcement Report
Sulfamethoxazole and Trimethoprim Tablets recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg unit dose, distributed nationwide in the US. The recall was initiated on 13 Apr 2022 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-1059-2022
- FDA event ID
- 89646
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2022
- FDA classified
- 9 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Antibiotics
Timeline
| 13 Apr 2022 | Recall initiated by company | |
| 9 Jun 2022 | Classified by FDA | +57 days |
| 15 Jun 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations: Temperature abuse
Product as listed by the FDA
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61
Where it was distributed
USA nationwide.
Questions about this recall
Is Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg unit dose recalled?
Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg unit dose on 13 Apr 2022. The recall is Class II and its status is Terminated. Recall number D-1059-2022.
Why was it recalled?
cGMP deviations: Temperature abuse
Which lots are affected?
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Where was it sold?
USA 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 21 Sep 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 Mckesson Medical-Surgical Inc. Corporate Office
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|---|---|---|---|---|---|
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Other Sulfamethoxazole recalls
All 10| 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 |