D-0052-2027 Class II Ongoing
FDA drug recall D-0052-2027 was initiated by Pfizer on Sep 29, 2026 and is designated Class II. Reason for recall: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing. The recall status is ongoing. Affected quantity: 15,815 100-count bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 28, 2026
- Initiation Date
- Sep 29, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,815 100-count bottles
Product description
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.
Reason for recall
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Distribution pattern
US Nationwide and Puerto Rico
Code information
Lot # 24W06, Exp: 11/30/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0052-2027
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026