CLASS I ONGOING Drug recall · Reported 17 May 2023 · FDA Enforcement Report
Atovaquone Oral Suspension USP, 750 mg recalled
Camber Pharmaceuticals is recalling Atovaquone Oral Suspension USP, 750 mg, distributed nationwide in the US. The recall was initiated on 13 Mar 2023 and the FDA has classified it as Class I.
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-0567-2023
- FDA event ID
- 91808
- Recalling firm
- Camber Pharmaceuticals, Piscataway, NJ
- Brand
- Atovaquone
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Mar 2023
- FDA classified
- 8 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Bacterial Contamination
Timeline
| 13 Mar 2023 | Recall initiated by company | |
| 8 May 2023 | Classified by FDA | +56 days |
| 17 May 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Product as listed by the FDA
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Which lots are affected?
Lot# E220182, Exp. 12/31/2023
Where was it sold?
Nationwide in the USA
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 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 Camber Pharmaceuticals
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lacosamide Oral Solution, USP, CV, 10mg/mL recalledLacosamide | Camber Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 25 mg recalled by Camber PharmaceuticalsLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 100 mg recalledLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 50 mg recalled by Camber PharmaceuticalsLosartan Potassium | Camber Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Atovaquone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension USP, 750 mg per sachets recalled by AvKARE | AvKARE | Other Bacterial Contamination | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | Kvk-Tech | Temperature Abuse | Nationwide |