Watson Recalls Loxapine Succinate Capsules Due to Outdated Patient Outsert
Watson Laboratories is recalling 7,262 bottles of Loxapine Succinate Capsules because an outdated patient outsert was used during packaging.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error.
Plain-English summary
Watson Laboratories Inc. is recalling 7,262 bottles of Loxapine Succinate Capsules, 10mg base, 100 count bottles. The product is identified by NDC # 52544-495-01 and Lot # 22478A. The recall was initiated because an outdated version of a patient outsert was used when the medication was packaged.
The affected product was distributed nationwide. This recall is classified as Class III by the FDA, indicating that the labeling error is unlikely to cause adverse health consequences.
Consumers who have this specific lot of Loxapine Succinate Capsules should contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
- Manufacturer
- Watson Laboratories Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,262
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 (1)
- Lot # 22478A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Watson Laboratories Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Watson Laboratories Inc
See all →- ModerateWatson Recalls Hydrocodone and Acetaminophen Tablets Due to Broken Tablets
FDA (Drugs) · 2014-02-05
- SevereWatson Recalls Carisoprodol Tablets Due to Metal Particulates
FDA (Drugs) · 2014-01-15
- ModerateWatson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage
FDA (Drugs) · 2013-10-16
- SevereWatson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination
FDA (Drugs) · 2013-10-09
- LowWatson Recalls Hydrocodone and Acetaminophen Tablets Due to Defective Seals
FDA (Drugs) · 2013-09-25
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02