FDA Recall
Terminated
Historical recordClass III
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139
by Care-Tech Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket RI 02895 NDC 59779-687-02 UPC 77815909639
by Raritan Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- January 4, 2017
- Distribution
- NY
View recall →
FDA Recall
Terminated
Historical recordClass II
Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption Blvd. Montreal, QC H1N 2H2 Canada NDC 60512-913-8 UPC 77815909639
by Raritan Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- January 4, 2017
- Distribution
- NY
View recall →
FDA Recall
Terminated
Historical recordClass II
CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 NDC 59779-860-03 UPC 0504284162
by Raritan Pharmaceuticals, Inc.
- Reason
- CGMP Deviations
- Published
- January 4, 2017
- Distribution
- NY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kerry, Inc
- Product
- Kerry Upgrade Bio WS, Net Wt. 50 lb (22068 kg), Item 5R01451…
- Reason
- Upgrade Bio WS has been identified as being adulterated with Bacillus cereus.
- Published
- January 4, 2017
- Distribution
- CT, FL, NY, and MN
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bio-Botanica, Inc.
- Product
- Liquid VITAMIN D-3 Drops distributed under the following pri…
- Reason
- The lots exceed the label claim for Vitamin D3 of 2000 IU per drop.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WD IMPORT AND EXPORT INC.
- Product
- DRIED SILVER FISH, N.W. 30 LBS, PRODUCT OF CHINA
- Reason
- Uneviscerated fish subject to IA 16-74, scheduled for destruction was distributed
- Published
- January 4, 2017
- Distribution
- NY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cargill Cocoa & Chocolate, Inc.
- Product
- Wilbur; IM10021; B558 Semisweet Chocolate Drops, 2000 CT; Ne…
- Reason
- Cargill Cocoa & Chocolate is recalling 50 lb. cartons of Wilbur B558 Semi-Sweet Chocolate Drops because it may contain undeclared milk.
- Published
- January 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
by Sage Products LLC
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
by Town and Country Compounding and Consultation Services
- Reason
- Non-Sterility; microbial contamination identified as Bacillus circulans
- Published
- December 28, 2016
- Distribution
- MA, NY, NJ & FL; Canada
View recall →
FDA Recall
Terminated
Historical recordClass I
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
by Making It a Lifestyle
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
by Hospira Inc., A Pfizer Company
- Reason
- Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
by VIRTUS PHARMACEUTICALS OPCO II L
- Reason
- Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
by Colonia Care Pharmacy
- Reason
- Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
- Published
- December 28, 2016
- Distribution
- NJ and NY
View recall →
FDA Recall
Terminated
Historical recordClass II
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
by Sage Products LLC
- Reason
- CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
by Sage Products LLC
- Reason
- Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
by Les Emballages Knowlton Inc.
- Reason
- Labeling: Label Mix Up- Incorrect back label applied to the product.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
by Love My Tru Body
- Reason
- Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
by Making It a Lifestyle
- Reason
- Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
- Published
- December 28, 2016
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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