Novartis Recalls No Doz Max Strength Caffeine Caplets Due to Packaging Defect
Novartis Consumer Health is recalling No Doz Max Strength caplets because the pouches may not be fully sealed.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (defective container) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for cosmetic or packaging-only issues.
Plain-English summary
Novartis Consumer Health, Inc. is recalling No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch. The recall involves 4,422,000 pouches distributed nationwide, in Puerto Rico, Brazil, and Panama.
The recall is being conducted because the products are packaged in pouches which may not have been fully sealed. This is a defective container issue.
Consumers should stop using the affected products and return them to the point of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 4,422,000
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 (16)
- Lot #s 10110263
- Exp 2/14
- 10114706
- Exp 4/14
- 10118209
- Exp 5/14
- 10120253
- Exp 7/14
- 10123520
- Exp 8/14
- 10095199
- Exp 7/13
- 10102536
- 11/2013
- 10103950
- Exp 12/13
Distribution
Part of a larger recall action
This product is one of 4 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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