FDA Drug recall D-239-2013
Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80)
- FDA Drug
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80) by Dr Reddys Laboratories Tennessee, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-239-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-15 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddys Laboratories Tennessee |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-239-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.