Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017,…
Pfizer · Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
- Status
- Ongoing
- City
- Manhattan
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99963
- Recalling firm
- Pfizer
- Address 1
- 66 Hudson Blvd
- Postal code
- 10001-2189
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide and Puerto Rico
- Recall number
- D-0051-2027
- Product quantity
- 134 1000-count bottles
- Reason for recall
- Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
- Recall initiation date
- 20260929
- Center classification date
- 20261016
- Report date
- 20261028
- Code info
- Lot # 24W07, Exp: 11/30/2026
- Product description
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
- Harmonized identifiers (openFDA)
- Application number
- NDA021301
- Brand name
- LEVOXYL
- Generic name
- LEVOTHYROXINE SODIUM
- Manufacturer name
- Pfizer Laboratories Div Pfizer Inc
- Product NDC
- 60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857, 60793-858, 60793-859, 60793-860
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Substance name
- LEVOTHYROXINE SODIUM
- RxCUI
- 892246, 892251, 966157, 966164, 966170, 966175, 966184, 966190, 966194, 966200, 966204, 966211, 966220, 966221, 966222, 966224, 966225, 966248, 966249, 966253, 966270, 966283
- SPL ID
- e230c170-2a16-47d0-bce7-ac0414c192f7
- SPL set ID
- 758588c3-c63e-491b-0aa2-4f50d80cb174
- Package NDC
- 60793-850-10, 60793-850-01, 60793-851-10, 60793-851-01, 60793-852-10, 60793-852-01, 60793-853-10, 60793-853-01, 60793-854-10, 60793-854-01, 60793-855-10, 60793-855-01, 60793-856-10, 60793-856-01, 60793-857-10, 60793-857-01, 60793-858-10, 60793-858-01, 60793-859-10, 60793-859-01, 60793-860-10, 60793-860-01
- Is original packager
- true
- Upc
- 0360793856018, 0360793850016, 0360793852010, 0360793851013, 0360793857015, 0360793853017, 0360793854014, 0360793858012, 0360793855011, 0360793859019, 0360793860015
- UNII
- 9J765S329G