Browse Drug Recalls
1,076 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,076 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 1,076 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Oct 5, 2012 | Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz... | Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final ... | Class II | Earthborn Products, Inc. |
| Sep 27, 2012 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-co... | Short Fill: some bottles contained less than 120-count per labeled claim. | Class III | Genentech, 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 |
| Sep 20, 2012 | Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genente... | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin A... | Class II | Genentech Inc |
| Sep 20, 2012 | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genente... | Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin A... | Class II | Genentech Inc |
| Aug 28, 2012 | Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metere... | Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indica... | Class II | Dispensing Solutions, Inc |
| Aug 27, 2012 | Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information ... | Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets beca... | Class I | Samantha Lynn, Inc |
| Jul 30, 2012 | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20... | Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials ... | Class I | Genentech Inc |
| Jul 27, 2012 | Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rin... | Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphing... | Class II | Capco Custom Packaging Inc |
| Jul 24, 2012 | OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single... | Presence of Particulate Matter: The firm initiated the recall due to visible presence of particul... | Class II | Cadence Pharmaceuticals |
| Jun 29, 2012 | Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottl... | Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dis... | Class II | Prometheus Laboratories Inc. |
| Jun 28, 2012 | Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 dose... | Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Fact... | Class III | Health Plus Incorporated |
| 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 |
| May 7, 2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... | Subpotent Drug: Salicylic acid is subpotent. | Class III | Guthy-Renker LLC |
| May 7, 2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... | Subpotent Drug: Salicylic acid is subpotent. | Class III | Guthy-Renker LLC |
| May 7, 2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... | Subpotent Drug: Salicylic acid is subpotent. | Class III | Guthy-Renker LLC |
| May 7, 2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... | Subpotent Drug: Salicylic acid is subpotent. | Class III | Guthy-Renker LLC |
| May 7, 2012 | Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic ... | Subpotent Drug: Salicylic acid is subpotent. | Class III | Guthy-Renker LLC |
| 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 |
| Dec 19, 2011 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, ... | Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA... | Class I | Body Basics Inc |
| Mar 1, 2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povid... | Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit car... | Class II | K C Pharmaceuticals 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.