CLASS III Drug recall · Reported 11 Jul 2012 · FDA Enforcement Report
Loxapine Capsules USP, 50mg recalled by Watson Laboratories
Watson Laboratories is recalling Loxapine Capsules USP, 50mg, distributed nationwide in the US. The recall was initiated on 17 Apr 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1402-2012
- FDA event ID
- 62383
- Recalling firm
- Watson Laboratories, Corona, CA
- Brand
- Loxapine
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Apr 2012
- FDA classified
- 29 Jun 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 17 Apr 2012 | Recall initiated by company | |
| 29 Jun 2012 | Classified by FDA | +73 days |
| 11 Jul 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Where it was distributed
Nationwide.
Questions about this recall
Is Loxapine Capsules USP, 50mg recalled?
Yes. Watson Laboratories recalled Loxapine Capsules USP, 50mg on 17 Apr 2012. The recall is Class III and its status is Terminated. Recall number D-1402-2012.
Why was it recalled?
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Which lots are affected?
Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |
Other Loxapine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Loxapine Capsules, USP 25 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine Capsules, USP 25 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine Capsules, USP 50 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine Capsules, USP 50 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Loxapine Capsules USP, 25mg recalled by Watson LaboratoriesLoxapine | Watson Laboratories | Packaging Defects | Nationwide |