Total records
16,790
Analyze FDA drug enforcement notices, including classifications, firms, and recall scope.
Total records
16,790
Most recent report
September 24, 2025
Last updated
September 30, 2025
Sorted by most recent report date.
Recall # | Product | Firm | Status | Classification | Report date |
---|---|---|---|---|---|
D-065-2013 | Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709. | GlaxoSmithKline, LLC. | Terminated | Class III | Dec 5, 2012 |
D-059-2013 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05 | Dr. Reddy's Laboratories, Inc. | Terminated | Class II | Nov 28, 2012 |
D-061-2013 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. | Church & Dwight Inc | Terminated | Class II | Nov 28, 2012 |
D-062-2013 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA | American Enterprises LLC dba Sterling Gelatin | Terminated | Class II | Nov 28, 2012 |
D-060-2013 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 | Ranbaxy Inc. | Terminated | Class II | Nov 28, 2012 |
D-058-2013 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. | Watson Laboratories Inc | Terminated | Class I | Nov 28, 2012 |
D-057-2013 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | Ongoing | Class I | Nov 28, 2012 |
D-054-2013 | All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | Ameridose LLC | Terminated | Class II | Nov 21, 2012 |
D-056-2013 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9. | ITW Dymon | Terminated | Class III | Nov 21, 2012 |
D-053-2013 | All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com | New England Compounding Center | Terminated | Class II | Nov 21, 2012 |
D-051-2013 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 | Stat Rx USA | Terminated | Class III | Nov 21, 2012 |
D-055-2013 | All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | Ameridose LLC | Terminated | Class II | Nov 21, 2012 |
D-050-2013 | Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, | Stat Rx USA | Terminated | Class III | Nov 21, 2012 |
D-052-2013 | All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com | New England Compounding Center | Terminated | Class II | Nov 21, 2012 |
D-045-2013 | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-049-2013 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-043-2013 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lotion (benzoyl peroxide 10% w/v) AFCS-0303-00, and 1-count 1 oz (28 g) bottle AFSV-0305-03, Retinol Renewal Complex per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12900 3. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-048-2013 | AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-046-2013 | AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-044-2013 | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-047-2013 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-042-2013 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 12008 6. | Valeant Pharmaceuticals | Terminated | Class III | Nov 14, 2012 |
D-040-2013 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. | Merit Medical Systems, Inc | Terminated | Class I | Nov 14, 2012 |
D-041-2013 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India | Aurobindo Pharma LTD | Terminated | Class II | Nov 14, 2012 |
D-035-2013 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | DermaCare, Inc. | Terminated | Class II | Nov 7, 2012 |