The Recall Desk
ModerateFDA (Drugs)·D-1056-2017·Announced 2017-08-09

Teva Recalls Famotidine Tablets Due to Weight Specification Failures

Teva Pharmaceuticals USA is recalling 28,188 bottles of Famotidine 20 mg tablets because they failed tablet weight specifications.

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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

Teva Pharmaceuticals USA is recalling 28,188 bottles of Famotidine Tablets USP, 20 mg, 100 count bottles. The recall involves Lot # 3429066 with an expiration date of 06/2018. The product is distributed nationwide.

The recall was initiated because the tablets failed to meet specifications for tablet weight. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this product should contact their pharmacist or healthcare provider for guidance on how to dispose of the medication or obtain a replacement.

The recalled product

Product
FAMOTIDINE (FAMOTIDINE)
Brand
FAMOTIDINE
Affected units
28,188

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 # 3429066
  • exp 06/2018

Distribution

Distributed nationwide across the United States.