Medicines, 2012
Shortlist up to four to read them side by side.
434 medicine recalls FDA’s Enforcement Report published in 2012, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
434of 434 medicine recallsshown with your filters
The list
- Medicine recall All Non-Sterile Products GMP deficiencies Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt. Class IIIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 14, 2012in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 14, 2012ClassClass IStatusTerminatedWhereConnecticut, Maryland, Ohio and South Carolina
- Medicine recall Northstar Zolpidem Tartrate Tablets USP 10 mg Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle… Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AcneFree 24 Hour Clearing System containing 1-count 4 fl oz Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v) Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic acid active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxide active ingredient. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall UP & UP brand, kid’s foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL… Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall UP & UP brand, kid’s foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s’melon,… Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leucovorin Calcium Injection USP, single use vials, 10mg/mL Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample. Class IIFDA’s classNov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 7, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall X-ROCK For Men, Dietary Supplement Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall X-ROCK 3 Day Pill For Men, supplied Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Z-ROCK All Natural Male Supplement. 1 capsule blister pack Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 7, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 7, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle Tablet Separation: Possibility of cracked or split coating on the tablets. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover). Class IIIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall BiCNU (Carmustine for injection) 100 mg and Diluent Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets,… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets… Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6… Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7… Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement,… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores… Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM… Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Children’s Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) Class IIIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One… Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. Class IIIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 17, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant. Class IIIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 17, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Moexipril HCl Tablets 7.5mg, 100 tabs Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure… Class IIFDA’s classOct 17, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 17, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point. Class IIIFDA’s classOct 10, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 10, 2012ClassClass IIIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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