Watson Laboratories Inc
Complete recall history across all FDA and CPSC categories — 22 total recalls
Watson Laboratories Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (22)
FDA drug safety enforcement actions by Watson Laboratories Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 15, 2014 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 10... | Failed Tablet/Capsule Specifications; Product contains broken tablets. | Class II |
| Dec 23, 2013 | Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactur... | Presence of Foreign Substance; metal particulates were visually observed in t... | Class II |
| Sep 23, 2013 | Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg... | Failed Tablet/Capsule Specifications: Multiple complaints for push through ta... | Class II |
| Sep 13, 2013 | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles... | Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg... | Class II |
| Aug 30, 2013 | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 ... | Defective Container: Defective bottles may not have tamper evident seals pro... | Class III |
| Jul 19, 2013 | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count... | Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 m... | Class III |
| Feb 13, 2013 | ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 ta... | Failed Tablet/Capsule Specification; tablet breakage while pushing through th... | Class II |
| Feb 8, 2013 | Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Wat... | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is rec... | Class II |
| Feb 8, 2013 | Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Wat... | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is rec... | Class II |
| Dec 13, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... | Impurities/Degradation Products: Out-of-specification results were obtained f... | Class III |
| Oct 19, 2012 | Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Nec... | Class II |
| Oct 19, 2012 | Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Nec... | Class II |
| Oct 19, 2012 | Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, in... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Nec... | Class II |
| Oct 19, 2012 | Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, ... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Nec... | Class II |
| Oct 19, 2012 | Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg,... | Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Nec... | Class II |
| Sep 21, 2012 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count... | Superpotent (Multiple Ingredient) Drug: There is the potential for oversized ... | Class I |
| Jun 5, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... | Impurities/Degradation Products: High Out-of-specification results were obtai... | Class III |
| Apr 17, 2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle,... | Labeling: Incorrect or Missing Package Insert: An outdated version of a pati... | Class III |
| Apr 17, 2012 | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Wats... | Labeling: Incorrect or Missing Package Insert: An outdated version of a pati... | Class III |
| Apr 17, 2012 | Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Wats... | Labeling: Incorrect or Missing Package Insert: An outdated version of a pati... | Class III |
| Apr 17, 2012 | Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watso... | Labeling: Incorrect or Missing Package Insert: An outdated version of a pati... | Class III |
| Apr 17, 2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson... | Labeling: Incorrect or Missing Package Insert: An outdated version of a pati... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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