Mayne Pharma Recalls Carbidopa and Levodopa Tablets Due to Foreign Tablet Mix-Up
Mayne Pharma is recalling specific bottles of Carbidopa and Levodopa Tablets because a foreign tablet was found in a bottle.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible health consequences. The hazard is a product mix-up (foreign tablet) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Mayne Pharma Inc is recalling 8,274 bottles of Carbidopa and Levodopa Tablets, USP 25 mg/250mg (100-count bottles). The recall is due to a product mix-up where a foreign tablet was found in a bottle.
The affected product is identified by Lot FG11514 with an expiration date of 05/2021. The NDC number is 51862-858-01. The product was distributed nationwide in the USA.
Consumers should check their medication for this specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
- Manufacturer
- Mayne Pharma Inc
- Category
- Drug — Prescription Medication
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 (1)
- Lot: FG11514 Exp. 05/2021
Distribution
Distributed nationwide across the United States.
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