Pfizer Recalls Levoxyl Levothyroxine Sodium Tablets Due to Superpotency
Pfizer is voluntarily recalling 1,996 bottles of Levoxyl 112 mcg tablets nationwide because the drug is superpotent.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard (superpotency of a prescription drug) without explicit reports of hospitalization or death maps to a score of 4 (Severe), as it is not Class I (Critical) but represents a serious potential for harm.
Plain-English summary
Pfizer Inc. is voluntarily recalling 1,996 bottles of Levoxyl (levothyroxine sodium tablets, USP) 112 mcg, 100-count bottles. The affected product is identified by Lot #18A18 with an expiration date of 01/2020 and NDC 60793-855-01. The recall was initiated on December 6, 2018, and the product was distributed nationwide within the United States.
The reason for the recall is that the drug is classified as "Superpotent." This means the tablets contain more active ingredient than the labeled amount, which can lead to adverse health effects in patients taking the medication. The FDA has classified this recall as Class II, 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 specific lot of Levoxyl should stop using it and contact their healthcare provider or pharmacist for guidance. The recall status is currently terminated, having been closed on October 8, 2020.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,996
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 #:18A18
- Exp. 01/2020
UPCs (11)
- 0360793856018
- 0360793850016
- 0360793852010
- 0360793851013
- 0360793857015
- 0360793853017
- 0360793854014
- 0360793858012
- 0360793855011
- 0360793859019
- 0360793860015
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOXYL
- HighLevoxyl 50 microgram levothyroxine tablets recalled as a subpotent drug
FDA (Drugs) · 2025-08-20
- ModerateCardinal Health Recalls LEVOXYL Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SeverePfizer Recalls LEVOXYL Levothyroxine Sodium Tablets Due to Superpotency
FDA (Drugs) · 2016-11-30
- ModerateLevoxyl Recall: Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2013-05-29
- ModerateLevoxyl Levothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2013-05-29
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · superpotency
See all →- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
- ModerateTriamcinolone Acetonide Cream USP Recalled for Out-of-Specification Potency Variance
FDA (Drugs) · 2024-11-27