Browse Drug Recalls
1,110 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,110 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 1,110 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 12, 2013 | Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl... | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... | Class II | OPMX, LLC |
| Apr 12, 2013 | Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL... | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being reca... | Class II | OPMX, LLC |
| Apr 10, 2013 | Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pil... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil,... | Class I | Affirm XL, Inc. |
| Apr 9, 2013 | Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Trav... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | (No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: B... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 9, 2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Wa... | CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated d... | Class II | Total Resources Intl |
| Apr 4, 2013 | Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextrom... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Mar 11, 2013 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-... | Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... | Class II | Gsms |
| Mar 11, 2013 | Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet ... | Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil whi... | Class I | Green Planet Inc |
| Feb 22, 2013 | Fludeoxyglucose F 18 Injection USP, 20-200 mCi/mL, Diagnostic - For Intraveno... | cGMP Deviation | Class II | Petnet Solution 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 |
| Jan 31, 2013 | Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on... | Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ... | Class I | Gilead Sciences, Inc. |
| Jan 18, 2013 | Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Wal-Mart Equate Tussin CF Adult Maximum Strength, Multi-Symptom Cold, (dextro... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextro... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 18, 2013 | Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorp... | Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was obser... | Class III | Aaron Industries Inc |
| Jan 16, 2013 | Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use ... | Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. | Class III | Actelion Pharmaceuticals U.S., Inc. |
| Dec 21, 2012 | 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 m... | Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeli... | Class II | Lee Pharmaceuticals, Inc |
| Dec 19, 2012 | SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19... | Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are ... | Class I | P & J Trading Co |
| Dec 17, 2012 | libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1,... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13... | Subpotent; bupivacaine | Class II | Pacira Pharmaceuticals, Inc. |
| Dec 17, 2012 | libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count bliste... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 co... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister ... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count bliste... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, Inc. |
| Dec 17, 2012 | BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual E... | Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and a... | Class I | Performance Plus Marketing, 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 |
| 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 |
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.