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Class II: temporary or reversible health riskTerminated

Abbott Laboratories Synthroid Recall

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott…

Abbott Laboratories · Abbott Park, IL

Risk level
Class II
Reported by FDA
Oct 3, 2012
Recall ID
D-1696-2012
Check your lot numberHow we source this data

Summary

Abbott Laboratories recalled Synthroid starting Jul 19, 2012. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1696-2012 on Oct 3, 2012. Reason: Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets. Status: Terminated.

Why it was recalled

Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.

Product description

Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90

Lot numbers, UPCs & expiration codes

Lot: 18355A8, Exp. 09/26/13

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1696-2012
Classification
Class II
Status
Terminated
Recall initiated
Jul 19, 2012
FDA report date
Oct 3, 2012
Quantity
40,464 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Abbott Laboratories

Original FDA data

Every field from FDA enforcement report D-1696-2012, exactly as published.

Show all FDA fields
City
Abbott Park
State
IL
Status
Terminated
Country
United States
Event ID
62674
Address
100 Abbott Park Rd
Code information
Lot: 18355A8, Exp. 09/26/13
Postal code
60064-3502
Report date
Oct 3, 2012
Product type
Drugs
Recall number
D-1696-2012
Classification
Class II
Recalling firm
Abbott Laboratories
Product quantity
40,464 Bottles
Termination date
Nov 1, 2013
Reason for recall
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
Distribution pattern
Nationwide
Recall initiation date
Jul 19, 2012
Initial firm notification
Letter
Center classification date
Sep 26, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1696-2012, published Oct 3, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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