Browse Drug Recalls
24 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 24 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 24 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 12, 2017 | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial... | Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. | Class III | Actavis Inc |
| 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 | Watson Laboratories Inc |
| 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 the tablets. | Class II | Watson Laboratories Inc |
| Sep 23, 2013 | Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg... | Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. | Class II | Watson Laboratories Inc |
| 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 were found in a sea... | Class II | Watson Laboratories Inc |
| 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 properly seated, and th... | Class III | Watson Laboratories Inc |
| 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 mg are being recalled... | Class III | Watson Laboratories Inc |
| 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 the blister pack (disp... | Class II | Watson Laboratories Inc |
| Feb 8, 2013 | Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Wat... | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ... | Class II | Watson Laboratories Inc |
| Feb 8, 2013 | Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Wat... | Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate ... | Class II | Watson Laboratories Inc |
| Dec 13, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... | Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities. | Class III | Watson Laboratories Inc |
| 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, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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, Necon, and Zenchent, be... | Class II | Watson Laboratories Inc |
| 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 and superpotent tabl... | Class I | Watson Laboratories Inc |
| Jul 11, 2012 | Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 ... | Subpotent; some patches may not contain fentanyl gel | Class II | Actavis |
| Jun 5, 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen)... | Impurities/Degradation Products: High Out-of-specification results were obtained for both known a... | Class III | Watson Laboratories Inc |
| Apr 17, 2012 | Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle,... | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used... | Class III | Watson Laboratories Inc |
| 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 patient outsert was used... | Class III | Watson Laboratories Inc |
| 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 patient outsert was used... | Class III | Watson Laboratories Inc |
| 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 patient outsert was used... | Class III | Watson Laboratories Inc |
| 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 patient outsert was used... | Class III | Watson Laboratories Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.