The Recall Desk
HighFDA (Drugs)·D-518-2014·Announced 2014-01-22

FDA Recalls Famotidine Tablets Due to Potential Labeling Errors

Aidapak Services is recalling 700-tablet bottles of 20 mg Famotidine tablets because they may be mislabeled as other medications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential mislabeling of medications, which poses a risk of harm if the wrong drug is taken, although no specific injuries are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Famotidine Tablet, 20 mg, Over The Counter, distributed by Aidapak Services, LLC. The recall involves 700-tablet bottles with NDC 16714036104. The agency identified a labeling issue where these tablets may be mislabeled as other drugs, including Carvedilol Phosphate ER, Duloxetine HCl DR, and Mycophenolate Mofetil.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots include W003226 (EXP: 6/17/2014), W003507 (EXP: 6/21/2014), W003508 (EXP: 6/21/2014), W003764 (EXP: 6/26/2014), and W003406 (EXP: 6/19/2014).

Consumers should check their medication bottles for the NDC 16714036104 and the specific pedigree codes listed above. If the medication matches these details, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on returning the product.

The recalled product

Product
FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
Affected units
700

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 (10)

  • FAMOTIDINE Tablet
  • 20 mg has the following codes Pedigree: W003226
  • EXP: 6/17/2014
  • Pedigree: W003507
  • EXP: 6/21/2014
  • Pedigree: W003508
  • Pedigree: W003764
  • EXP: 6/26/2014
  • Pedigree: W003406
  • EXP: 6/19/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC 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 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →