CLASS II Drug recall · Reported 10 Apr 2013 · FDA Enforcement Report
Amoxicillin for Oral Suspension, 125mg/, a) recalled
Dr Reddys Laboratories Tennessee is recalling Amoxicillin for Oral Suspension, 125mg/, a) (, distributed nationwide in the US. The recall was initiated on 15 Feb 2013 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-239-2013
- FDA event ID
- 64405
- Recalling firm
- Dr Reddys Laboratories Tennessee, Bristol, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2013
- FDA classified
- 2 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Antibiotics
Timeline
| 15 Feb 2013 | Recall initiated by company | |
| 2 Apr 2013 | Classified by FDA | +46 days |
| 10 Apr 2013 | 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
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #s: a) T200112; b) T200103, T200113; c) T200104, T200114
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 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.
Other Amoxicillin For recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 125 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Amoxicillin for Oral Suspension USP, 125 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | PR |
| Drug | CLASS III | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg recalled | West-Ward Pharmaceuticals | Other | Nationwide |