Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie I...
FDA Drug Recall #D-0088-2024 - Class III, October 17, 2023
Recall Summary
| Recall Number | D-0088-2024 |
| Classification | Class III, Low risk |
| Date Initiated | October 17, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | AbbVie Inc. |
| Location | North Chicago, IL |
| Product Type | Drugs |
| Quantity | 864 cartons |
Product Description
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Reason for Recall
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Distribution Pattern
Distributed in the US. No government or foreign consignees.
Lot / Code Information
Lot # 1187435 exp date: 02/2024
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|---|---|---|---|
| D-0551-2026 | Class III | PRED MILD, prednisolone acetate ophthalmic susp... | May 18, 2026 |
| D-0664-2024 | Class II | Refresh P.M., (Mineral Oil 42.5%, White Petrola... | Sep 16, 2024 |
| D-0665-2024 | Class II | Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% W... | Sep 16, 2024 |
| D-0412-2018 | Class III | Ultane (sevoflurane), 250 mL, Inhalation Anesth... | Jan 22, 2018 |
| D-0034-2018 | Class III | AndroGel (testosterone gel) 1.62%, 40.5mg in 2.... | Sep 8, 2017 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.