Amoxicillin for Oral Suspension — Class II drug recall D-239-2013
Terminated recall by Dr Reddys Laboratories Tennessee LLC, reported 2013-04-10, distributed nationwide. Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL s
| Recall number | D-239-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr Reddys Laboratories Tennessee LLC, Bristol, TN, United States |
| Recall initiated | 2013-02-15 |
| Classified | 2013-04-02 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2013-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,236 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold, yeast |
| NDC | 43598-0222-52, 43598-0222-53, 43598-0222-80 |
Product
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807
Reason for recall
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-239-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.