Class I · Posted November 26, 2025 · Started October 29, 2025 · Ongoing
potassium chloride
- Product
- 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
- Firm
- Otsuka ICU Medical LLC, Austin, TX
- 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
- Lots
- Lot # 1030613, Exp Date: 09/30/2026
- Distribution
- US Nationwide.
- RxNorm
- potassium chloride (RxCUI 312507, 1860239, 1860241, 1860463, 1860466)
- Recall number
- D-0181-2026
Class I · Posted November 26, 2025 · Started October 29, 2025 · Ongoing
potassium chloride
- Product
- 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
- Firm
- Otsuka ICU Medical LLC, Austin, TX
- 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
- Lots
- Lot # 1030613, Exp Date: 09/30/2026
- Quantity
- 21,696 50mL flexible containers
- Distribution
- US Nationwide.
- RxNorm
- potassium chloride (RxCUI 312507, 1860239, 1860241, 1860463, 1860466)
- Recall number
- D-0180-2026
Class II · Posted November 26, 2025 · Started October 23, 2025 · Ongoing
bromocriptine mesylate
- Product
- Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
- Firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- Lots
- Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26
- Quantity
- 36,624 bottles
- Distribution
- Nationwide in the USA
- RxNorm
- bromocriptine mesylate (RxCUI 197412)
- Recall number
- D-0159-2026
Class II · Posted November 26, 2025 · Started October 20, 2025 · Ongoing
niacin
- Product
- NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
- Firm
- Golden State Medical Supply Inc., Camarillo, CA
- Reason
- Failed Dissolution Specifications
- Lots
- Lot, expiry: GS044385, exp 10/2025 ; GS044979, exp 10/2025 ; GS045797, exp 12/2025 ; GS046415, exp 12/2025 ; GS047197, exp 02/2026 ; GS047786, exp 02/2026 ; GS048477, exp 02/2026 ; GS049480, exp 03/2026 ; GS048873, exp 03/2026 ; GS049733, exp 03/2026 ; GS050224, exp 03/2026 ; GS050721, exp 03/2026 ; GS050722, exp 03/2026 ; GS051145, exp 03/2026 ; GS051726, exp 03/2026 ; GS052484, exp 03/2026 ; GS053612, exp 04/2026 ; GS054987, exp 05/2026 ; GS054409, exp 05/2026 ; GS055697, exp 05/2026 ; GS056192, exp 05/2026 ; GS056886, exp 05/2026 ; GS058077, exp 05/2026 ; GS057330, exp 05/2026
- Quantity
- 24,869 bottles
- Distribution
- Nationwide in the USA
- RxNorm
- niacin (RxCUI 1098134, 1098141)
- Recall number
- D-0158-2026
Class III · Posted November 26, 2025 · Started October 20, 2025 · Ongoing
Klarity-C Drops (Cyclosporine) 0.1%
- Product
- Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
- Firm
- Imprimis NJOF, LLC, Ledgewood, NJ
- Reason
- Subpotent Drug
- Lots
- Lot #:25JAN029, exp. date 07Nov2025; 25JAN042, exp. date 14Nov2025; 25JAN054, exp. date 21Nov2025; 25MAR021, exp. date 07Dec2025; 25APR017, exp. date 04Jan2026, 25APR025, exp. date 05Jan2026; 25MAY032, exp. date 31Jan2026; 25MAY055, exp. date 12Mar2026; 25MAY057, exp. date 14Mar2026; 25MAY073, exp. date 21Mar2026
- Quantity
- 67,091 bottles
- Distribution
- USA nationwide
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0157-2026
Class III · Posted November 26, 2025 · Started October 10, 2025 · Ongoing
fesoterodine fumarate
- Product
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
- Firm
- Alembic Pharmaceuticals Limited, Panchmahal, India
- Reason
- Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
- Lots
- Lot # 2405006633, Exp Date: 03/31/2026
- Quantity
- 4,884 30-count bottles
- Distribution
- Nationwide in the USA.
- RxNorm
- fesoterodine fumarate (RxCUI 810071, 810077)
- Recall number
- D-0156-2026
Class II · Posted November 26, 2025 · Started September 23, 2025 · Ongoing
Fentanyl citrate
- Product
- Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
- Firm
- Park Avenue Compounding, Saint Louis, MO
- Reason
- CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
- Lots
- Lot # 20250507-01D93C, Exp Date: 11-04-2025
- Quantity
- 189 bags
- Distribution
- Distributed in Missouri
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0178-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
UltraSure Anti-Perspirant & Deodorant
- Product
- 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
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 37,379 spray bottles
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0177-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
San-E-Foam
- Product
- 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
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 15,465 cartridges
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0176-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
Renew Skin Repair Cream
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 57,041 units
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0175-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
Renew PeriProtect
- Product
- 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
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 37,272 tubes
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0174-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
PeriGuard Ointment
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 381,619 units
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0173-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
PeriGiene
- Product
- 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
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 16,006 units
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0172-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
lanolin
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 5,876 units
- Distribution
- Nationwide in the USA
- RxNorm
- lanolin (RxCUI 1038957)
- Recall number
- D-0171-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
Lantiseptic
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 57,837 units
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0170-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
Lantiseptic
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 8,378 containers
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0169-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
KleenFoam Antimicrobial Foam Soap
- Product
- 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
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 15,267 cartridges
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0168-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
Hand-E-Foam
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 576 containers
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0167-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
GelRite Instant Hand Sanitizer
- Product
- 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.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 115,994 containers
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0166-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
DermaSarra
- Product
- DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 2,389 bottles
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0165-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
DermaMed Ointment
- Product
- DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 2,673 tubes
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0164-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
DermaKleen
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 7,736 tubes
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0163-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
DermaFungal
- Product
- DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Quantity
- 1,480 packets
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0162-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
DermaCerin
- Product
- DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0161-2026
Class II · Posted November 26, 2025 · Started August 27, 2025 · Ongoing
4-N-1 Skin Protectant
- Product
- 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
- Firm
- DermaRite Industries, LLC, North Bergen, NJ
- Reason
- CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Lots
- All lots on or before expiry date 08/2027.
- Quantity
- 3,178 bottles
- Distribution
- Nationwide in the USA
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0160-2026