FDA Drug recall D-823-2013
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737…
- FDA Drug
- Class III
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class III recall of Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737… by Watson Laboratories, citing subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months)….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-823-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-07-19 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | US |
Product
Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
Reason
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Identifiers
| code_info | Lot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Watson Laboratories
- Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only
FDA Drug · Class II · 2014-02-05 · Watson Laboratories - Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only
FDA Drug · Class II · 2014-01-15 · Watson Laboratories - Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Wa…
FDA Drug · Class II · 2013-10-16 · Watson Laboratories - Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc
FDA Drug · Class II · 2013-10-09 · Watson Laboratories - Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocon…
FDA Drug · Class III · 2013-09-25 · Watson Laboratories
All Watson Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-823-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.