FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 23 of 348
Moderate May 22, 2024
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltim…
Lupin Pharmaceuticals Inc.
Critical May 15, 2024
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Pr…
Dr. Reddy's Laboratories, Inc.
Moderate May 15, 2024
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manu…
FDC Limited
Moderate May 15, 2024
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: …
SUN PHARMACEUTICAL INDUSTRIES INC
Critical May 15, 2024
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratori…
Dr. Reddy's Laboratories, Inc.
Moderate May 15, 2024
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Dist…
Aurobindo Pharma USA Inc.
Moderate May 15, 2024
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blis…
RemedyRepack Inc.
Moderate May 15, 2024
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsb…
Rubicon Research Private Limited
Moderate May 15, 2024
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Dist…
Aurobindo Pharma USA Inc.
Moderate May 15, 2024
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain…
Breckenridge Pharmaceutical, Inc
Moderate May 15, 2024
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by:…
Breckenridge Pharmaceutical, Inc
Moderate May 15, 2024
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Sp…
Breckenridge Pharmaceutical, Inc
Low May 15, 2024
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 4…
Acella Pharmaceuticals, LLC
Moderate May 8, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route…
Imprimis NJOF, LLC
Low May 8, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B…
Imprimis NJOF, LLC
Low May 8, 2024
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Est…
Hikma Injectables USA Inc
Moderate May 8, 2024
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 692…
Amneal Pharmaceuticals of New York, LLC
Low May 8, 2024
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Viatris Inc
Moderate May 8, 2024
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceutic…
Regeneron Pharmaceuticals Inc
Critical May 1, 2024
Weiner Boner Honey, 12g packet, 100% Organic Formula.
Pyramids Wholesale Inc.
Critical May 1, 2024
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 o…
Aruba Aloe Balm N.V.
Critical May 1, 2024
Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
Pyramids Wholesale Inc.
Critical May 1, 2024
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
FA Online Inc
Critical May 1, 2024
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, D…
Aruba Aloe Balm N.V.
Moderate May 1, 2024
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 cart…
Nomax Inc
Moderate May 1, 2024
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 1747…
Nomax Inc
Critical May 1, 2024
Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
Pyramids Wholesale Inc.
Low May 1, 2024
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Critical May 1, 2024
Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
Pyramids Wholesale Inc.
Critical May 1, 2024
Samurai-X Honey 6800, UPC 2 56891 27553 3.
Pyramids Wholesale Inc.
Moderate May 1, 2024
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouch…
Cipla USA, Inc.
Low May 1, 2024
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Moderate May 1, 2024
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufa…
EPI Health, LLC
Low May 1, 2024
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, O…
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Critical May 1, 2024
ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
Pyramids Wholesale Inc.
Critical May 1, 2024
HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
Pyramids Wholesale Inc.
Critical May 1, 2024
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Pyramids Wholesale Inc.
Critical May 1, 2024
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.
Pyramids Wholesale Inc.
Moderate May 1, 2024
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Hi…
HONEYWELL INC
Moderate May 1, 2024
GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, N…
Nomax Inc
Moderate May 1, 2024
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC …
EPI Health, LLC
Moderate May 1, 2024
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Fo…
Nomax Inc
Moderate May 1, 2024
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharm…
Glenmark Pharmaceuticals Inc., USA
Critical May 1, 2024
libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
Pyramids Wholesale Inc.
Low May 1, 2024
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Moderate May 1, 2024
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufa…
EPI Health, LLC
Critical May 1, 2024
GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
Pyramids Wholesale Inc.
Moderate Apr 24, 2024
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01,…
Specialty Process Labs LLC
Critical Apr 24, 2024
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086…
AvKARE
Moderate Apr 24, 2024
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, …
Eli Lilly & Company