Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Amoxicillin for Oral Suspension Recalled by Dr Reddys Laboratories Tennessee LLC Due to Microbial Contamination of Non-Sterile Products: Suspensions made from...

Date: February 15, 2013
Company: Dr Reddys Laboratories Tennessee LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Dr Reddys Laboratories Tennessee LLC directly.

Affected Products

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

Quantity: 4236 Bottles

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Dr Reddys Laboratories Tennessee LLC

Dr Reddys Laboratories Tennessee LLC has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report