Pfizer Recalls LEVOXYL Levothyroxine Sodium Tablets Due to Superpotency
Pfizer is voluntarily recalling 2,666 bottles of LEVOXYL (levothyroxine sodium) 200 mcg tablets nationwide because the product is superpotent.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall. According to the rubric, an FDA Class II recall with a significant hazard (superpotency of a thyroid hormone) maps to a severity score of 4 (Severe), as it is not Class I (Critical) but involves a potential for adverse health consequences.
Plain-English summary
Pfizer Inc. is voluntarily recalling 2,666 bottles of LEVOXYL (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles. The product is prescription-only and was manufactured and distributed by King Pharmaceuticals, Inc. The specific lot code is 16H21, with an expiration date of 08/2017.
The recall was initiated because the product is superpotent, meaning it contains more of the active ingredient than labeled. This is an FDA Class II recall, which indicates a situation that may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot and stop using the product if it matches the description. The recall was initiated on November 7, 2016, and was terminated on May 1, 2020.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,666
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)
- 16H21
- Exp. 08/2017
UPCs (11)
- 0360793856018
- 0360793850016
- 0360793852010
- 0360793851013
- 0360793857015
- 0360793853017
- 0360793854014
- 0360793858012
- 0360793855011
- 0360793859019
- 0360793860015
Distribution
Distributed nationwide across the United States.
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