Pfizer Recalls Zoloft Tablets Due to Weight Variations
Pfizer is recalling 1,972 bottles of Zoloft 25 mg tablets because weight variations caused some tablets to be sub or super potent.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant deviations in drug potency that could impact patient safety.
Plain-English summary
Pfizer Inc. is recalling 1,972 bottles of Zoloft (sertraline HCl) 25 mg tablets, 30-count bottles. The recall is due to weight variations in the tablets, which resulted in some tablets being sub-potent (containing less active ingredient than labeled) and others being super-potent (containing more active ingredient than labeled).
The affected product is identified by Lot S84026 and NDC 0049-4960-30. The product was distributed nationwide in the United States. This is a prescription-only medication.
Consumers who have this specific lot of Zoloft should contact their healthcare provider or pharmacist for guidance on what to do with the medication.
The recalled product
- Product
- Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,972
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 (1)
- Lot: S84026
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.
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