Dr. Reddy's Recalls Amoxicillin Oral Suspension Due to Microbial Contamination
Dr. Reddy's is recalling specific lots of Amoxicillin for Oral Suspension because testing revealed yeast and mold growth.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
Dr. Reddy's Laboratories Tennessee LLC is recalling 4,236 bottles of Amoxicillin for Oral Suspension, 125mg/5mL, in 80 mL, 100 mL, and 150 mL sizes. The affected products are prescription-only and were distributed nationwide.
The recall was initiated because microbial testing showed yeast and mold growth at the 14-day time point for suspensions made from these specific lots. The affected lot numbers are T200112 (80 mL), T200103 and T200113 (100 mL), and T200104 and T200114 (150 mL).
Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If found, the product should be discontinued and returned to the distributor or disposed of according to local regulations.
The recalled product
- 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
- Manufacturer
- Dr Reddys Laboratories Tennessee LLC
- Category
- Drug — Antibiotic
- Affected units
- 4,236
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #s: a) T200112
- b) T200103
- T200113
- c) T200104
- T200114
Distribution
Distributed nationwide across the United States.
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