Apotex Recalls Meloxicam Tablets Due to Slightly Oversized Tablet
Apotex Corp. is recalling 1,749 bottles of Meloxicam 15 mg tablets because one bottle contained a slightly oversized tablet.
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 and involves a physical defect (oversized tablet) that poses a low risk of harm, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Apotex Corp. is recalling 1,749 bottles of Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle. The product was manufactured by Strides Acrolab Ltd. in Bangalore, India, for Apotex Corp. in Weston, FL. The specific lot number is 7212558 with an expiration date of 12/12.
The recall was initiated because one slightly oversized tablet was found in a bottle of the identified lot. The agency classified this recall as Class II. The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for this specific lot and expiration date. If found, the product should be returned to the pharmacy or supplier for a refund or replacement.
The recalled product
- Product
- Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
- Manufacturer
- Apotex Corp.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 1,749
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 (2)
- Lot: 7212558
- Exp 12/12.
Distribution
Distributed nationwide across the United States.
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