FDA Recall
Ongoing
Historical recordClass III
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Published
- December 10, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
by Teva Pharmaceuticals USA, Inc
- Reason
- Defective Container - A defect in the side-seal which allows leakage of product.
- Published
- December 10, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
by Cipla Limited
- Reason
- Failed Stability Specifications: Observed OOS results: eg results for colour index
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Water Pure, Inc.
- Product
- My Bladder; Supports normal bladder tone & control; Dietary…
- Reason
- Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
- Published
- December 10, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
by Fresenius Kabi USA, LLC
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Published
- December 3, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
by Medical Products Laboratories, Inc.
- Reason
- Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
- Published
- December 3, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
by Otsuka ICU Medical LLC
- Reason
- Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
by Otsuka ICU Medical LLC
- Reason
- Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
by DermaRite Industries, LLC
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Published
- November 26, 2025
- 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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