FDA Recall
Ongoing
Historical recordClass II
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.
by Nomax Inc
- Reason
- Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123.
by Nomax Inc
- Reason
- Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
by HONEYWELL INC
- Reason
- CGMP Deviations
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
by Aruba Aloe Balm N.V.
- Reason
- Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean.
by Aruba Aloe Balm N.V.
- Reason
- Chemical Contamination: Product manufactured with ethanol API that contains methanol
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Samurai-X Honey 6800, UPC 2 56891 27553 3.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Weiner Boner Honey, 12g packet, 100% Organic Formula.
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
by Pyramids Wholesale Inc.
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
by Specialty Process Labs LLC
- Reason
- Failed Stability Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
by Eli Lilly & Company
- Reason
- CGMP Deviations
- Published
- April 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
by Novitium Pharma LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- April 24, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Superpotent Drug: Due to overfilling of drug powder
- Published
- April 24, 2024
- 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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