Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications
Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.
What this means for you
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 defect (thick tablets) is a physical specification failure without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pfizer Inc. is recalling 68,214 bottles of Zoloft (sertraline HCl) 100 mg tablets, 30 count, NDC 0049-4910-30. The recall was initiated because thick tablets exceeding specifications were found. The affected lot number is M25569 with an expiration date of 08/18.
The recalled product was distributed nationwide and in Puerto Rico. This is a prescription-only medication distributed by Roerig, Division of Pfizer, Inc.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall details, they should contact their healthcare provider or pharmacist for guidance on returning the medication or obtaining a replacement.
The recalled product
- Product
- Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 #: M25569
- Exp 08/18
Distribution
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