FDA Drug recall D-1053-2014
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only by Watson Laboratories, citing failed Tablet/Capsule Specifications; Product contains broken tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1053-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-15 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | AZ, CA, CT, FL, NV, OH, OK, PA, SC, WI |
Product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
Reason
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Identifiers
| code_info | Lot #: 697316A, Expiry: Mar 2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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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 - 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 · 2013-07-31 · Watson Laboratories
All Watson Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1053-2014%22
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