Pfizer Recalls Caduet Tablets Due to Defective Bottle Seals
Pfizer is recalling 128 bottles of Caduet (amlodipine and atorvastatin) because defective bottle rims may have caused inadequate foil sealing, potentially compromising moisture protection.
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 corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences but may cause temporary or medically reversible issues.
Plain-English summary
Pfizer Inc. is recalling 128 bottles of Caduet (amlodipine besylate/atorvastatin calcium) tablets, 10 mg/10 mg, 30-count bottles. The affected product is identified by Lot # CY0963 with an expiration date of 07/2022. The recall was initiated because the products may have been packaged in defective bottles with a notched rim, which could result in inadequate foil sealing and a lack of moisture protection.
The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The affected units were distributed nationwide in the USA.
Consumers and healthcare providers should check their inventory for Caduet tablets with Lot # CY0963 and expiration date 07/2022. If found, these products should be returned to the pharmacy or point of purchase for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they are currently using the recalled product.
The recalled product
- Product
- CADUET (AMLODIPINE AND ATORVASTATIN)
- Brand
- CADUET
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 128
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 #: CY0963
- Exp 07/2022
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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