Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals
Pfizer is recalling 141 bottles of Caduet tablets because defective bottle rims may have allowed moisture to enter, potentially compromising the medication.
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 the hazard involves potential moisture exposure due to packaging defects, which fits the criteria for moderate severity involving low-risk contamination or packaging issues.
Plain-English summary
Pfizer Inc. is recalling 141 bottles of Caduet (amlodipine and atorvastatin) tablets, 10 mg/20 mg, 30-count bottles. The recall affects Lot CY0937 with an expiration date of 12/2021. The product was distributed nationwide in the USA.
The recall was initiated because the products may have been packaged in defective bottles with a notched rim. This defect could cause inadequate foil sealing, resulting in a lack of moisture protection for the medication.
Consumers who have this specific lot of Caduet should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot number and expiration date identified in the notice.
The recalled product
- Product
- CADUET (AMLODIPINE AND ATORVASTATIN)
- Brand
- CADUET
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 141
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 #: CY0937
- Exp 12/2021
UPCs (15)
- 0300692150305
- 0300692250302
- 0300692170303
- 0300692160304
- 0300692190301
- 0300696565303
- 0300696747303
- 0300697810303
- 0300692270300
- 0300697232303
- 0300697476301
- 0300696180308
- 0300696323309
- 0300692260301
- 0300697654303
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. 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.
See all 2 products in this recall →Related recalls
Same brand · CADUET
- ModeratePfizer Recalls Caduet Tablets Due to Defective Bottle Seals
FDA (Drugs) · 2020-02-19
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