INFORMACIÓN DIARIA DE RETIROS DE LA FDA

Medicamentos retirados, NDC y datos de lotes.

Esta página solicita los reportes más recientes directamente del servicio oficial openFDA cada vez que se abre. Los números NDC aparecen solamente cuando la FDA los incluye en la descripción. La información de lote, partida y vencimiento se reproduce del campo oficial de códigos de la FDA.

●Verificado October 13, 2026 at 1:23 PM ET
Do not stop a medication based only on this page.Compare the exact medication name, NDC, lot/batch and expiration with the original FDA notice. Contact the dispensing pharmacy, manufacturer, veterinarian or appropriate licensed clinician for product-specific instructions. For urgent symptoms or emergencies, contact emergency services.

HUMAN MEDICATIONS

Latest FDA drug recall reports

30 reports shown
Class IID-0879-2026

Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.

NDC0536-1261-63, 0536-1351-42

Lot / batch / code informationa) Lot #: 0575-01-366, Exp. Date Jan-27; 0565-02-336, Exp. Date FEB-27; b) Lot #: 0645-02-355, 0575-02-336, Exp. Date Feb-27; 0565-12-317, Exp. Date Dec-26

Recalling companySV Labs Toronto Corporation

Recall initiated09/01/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Microbial contamination of topical product.

Distribution: IL only

Class IID-0873-2026

Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.

NDC69238-2452-3

Lot / batch / code informationLot # 245226005B, Exp Date: 04/30/2028.

Recalling companyAmneal Pharmaceuticals, LLC

Recall initiated09/08/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Defective Container; packets were found to be either empty or partially full.

Distribution: Nationwide in the USA.

Class IID-0874-2026

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19

NDC82724-007-19

Lot / batch / code informationBatch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28

Recalling companyAurolab Trust

Recall initiated09/17/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: VA

Class IID-0875-2026

Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Switzerland, website at www.zoladex.com, NDC 70720-950-36.

NDC70720-950-36

Lot / batch / code informationLot#: YN0099, Exp 01/31/2028

Recalling companyTerSera Therapeutics LLC

Recall initiated08/31/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

Distribution: USA Nationwide

Not Yet ClassifiedRecall number not provided

amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0

NDC72288-692-01

Lot / batch / code informationLot# ACD124048A, Exp Date: 11/30/2027.

Recalling companyAurobindo Pharma USA Inc

Recall initiated09/18/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Discoloration: consumer complaints received for discolored tablets

Distribution: US Nationwide.

Class IID-0877-2026

Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-1318-3

NDC60505-1318-3

Lot / batch / code informationLot# TY9495, Exp Date: 05/2027.

Recalling companyApotex Corp.

Recall initiated09/23/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed dissolution specifications.

Distribution: US Nationwide.

Class IID-0878-2026

Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63

NDC0536-1259-63

Lot / batch / code informationLot #: 0525-02-345, Exp. Date 02/2027

Recalling companySV Labs Toronto Corporation

Recall initiated09/01/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Microbial contamination of topical product.

Distribution: IL only

Class IID-0876-2026

Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05

NDC42023-179-05

Lot / batch / code informationLot#:83912, Exp Date 10/2026 Lot#:84234, Exp Date 11/2026 Lot#:84990, Exp Date 11/2026 Lot#:85003, Exp Date 12/2026 Lot#:86443, Exp Date 01/2027 Lot#:89909, Exp Date 05/2027

Recalling companyPar Health USA, LLC

Recall initiated09/08/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Crystallization

Distribution: U.S. Nationwide

Class IID-0010-2027

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

NDC27241-126-02

Lot / batch / code informationLot: DJ25134, Exp 11/30/2028

Recalling companyAjanta Pharma USA Inc

Recall initiated09/17/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Dissolution Specifications: below specification

Distribution: Nationwide in the US.

Class IID-0860-2026

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.

NDC17312-430-15

Lot / batch / code informationLot # 3279, Exp 6/30/2027; Lot # 3292, Exp 5/31/2027.

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0863-2026

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)

NDC50268-068-02

Lot / batch / code informationLot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0871-2026

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15

NDC67172-797-15

Lot / batch / code informationLot #: RL25G04, Exp. Date 07/2027; RL2H02, Exp. Date 08/2027.

Recalling companyInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Recall initiated09/15/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: Nationwide in the USA.

Class IID-0855-2026

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15

NDC50268-068-15

Lot / batch / code informationLot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0862-2026

Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05

NDC42494-448-05

Lot / batch / code informationLot # 3163, Expiry: 8/31/2026; Lot# 3164, Expiry: 9/30/2026.

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0856-2026

Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.

NDC69618-077-55

Lot / batch / code informationLot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0858-2026

Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.

NDC0363-8833-15

Lot / batch / code informationLot # 3165, Expiry: 9/2026; Lot # 3179, Expiry: 10/2026; Lot # 3204, Expiry: 12/2026; Lot #3206, Expiry: 12/2026, Lot # 3208, Expiry: 12/2026; Lot #3259, Expiry: 4/2027; Lot #: 3265, Expiry: 5/2027; Lot # 3268; Expiry 6/2027; Lot #3272, Expiry: 5/2027; Lot # 3273, Expiry: 6/2027; Lot #3276, Expiry: 6/2027; Lot # 3278, Expiry: 6/2027; Lot # 3280, Expiry: 6/2027; Lot # 3307, Expiry: 7/2027; Lot # 3309, Expiry: 7/2027; Lot # 3315, Expiry: 7/2027.

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0868-2026

Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1

NDC70121-1685-1

Lot / batch / code informationLot #: AP250095A, Exp 2/28/2027

Recalling companyAmneal Pharmaceuticals of New York, LLC

Recall initiated08/28/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Defective Delivery System: Possibility of no medication in the prefilled pen.

Distribution: USA Nationwide

Class IIID-0867-2026

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.

NDC33342-068-07

Lot / batch / code informationLot: BOB22321A, Exp 07-31-2027.

Recalling companyMacleods Pharmaceuticals Limited

Recall initiated08/27/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Distribution: Nationwide in the USA

Class IID-0861-2026

Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38

NDC0904-6488-38

Lot / batch / code informationLot # 3183

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0857-2026

Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.

NDC0363-8833-15

Lot / batch / code informationLot # 3166, Expiry: 9/2026; Lot # 3172, Expiry: 9/2026; Lot # 3173, Expiry: 9/2026; Lot # 3175, Expiry: 10/2026; Lot # 3176, Expiry: 10/2026; Lot # 3177, Expiry: 10/2026; Lot # 3178, Expiry:10/2026; Lot # 3180, Expiry: 11/2026; Lot # 3188, Expiry: 12/2026; Lot # 3202, Expiry: 12/2026; Lot # 3203, Expiry: 12/2026; Lot # 3205, Expiry: 12/2026; Lot # 3209, Expiry: 2/2027; Lot #3210, Expiry: 3/2027; Lot #3246, Expiry: 3/2027; Lot #3247, Expiry: 3/2027; Lot #3248, Expiry: 4/2027; Lot # 3249, Expiry: 4/2027; Lot # 3250, Expiry: 4/2027; Lot # 3252, Expiry: 4/2027; Lot # 3253, Expiry: 4/2027; Lot # 3261, Expiry: 5/2027; Lot # 3262, Expiry: 5/2027; Lot # 3263; Expiry 5/2027; Lot #3264, Expiry: 5/2027; Lot #3281, Expiry : 6/2027.

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0870-2026

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15

NDC67172-797-15

Lot / batch / code informationLot #: RL25G02, RL25G03, RL25G04, Exp. Date Jul-27; RL25H02, RL25H03, RL25H04, Exp. Date Aug-27; RL25K01, RL25K02, RL25K03, RL25K04, Exp. Date Sep-27; RL25M01, RL25M02, RL25M03, RL25M04, Exp. Date Oct-27; RL25N01, RL25N02, RL25N04, Exp. Date Nov-27.

Recalling companyInsight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Recall initiated09/15/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: Nationwide in the USA.

Class IID-0859-2026

Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

NDC69618-076-55

Lot / batch / code informationLot # 3171, Expiration Date 09/30/2026. Lot # 3174, Expiration Date 10/31/2026; Lot #3275, Expiration Date, 06/30/2027; Lot #3304, Expiration date 07/31/2027.

Recalling companySterling Pharmaceutical Services LLC

Recall initiated08/20/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Lack of Assurance of Sterility

Distribution: USA Nationwide

Class IID-0854-2026

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China

NDCNot listed in FDA product description

Lot / batch / code informationLot #: 2024/10/11, Exp. Date 10/10/2027

Recalling companySHANTOU Qiwei industrial Co., Ltd

Recall initiated08/08/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: cGMP Deviations

Distribution: CA only

Class IID-0845-2026

Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

NDC00121-0653-04

Lot / batch / code informationLot#:26080483; Exp :03/13/2027 Lot#:25310327; Exp :08/12/2026 Lot#:25330414; Exp :08/26/2026 Lot#:25430340; Exp :11/22/2026

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

Class IID-0846-2026

Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

NDC00121-0653-04

Lot / batch / code informationLot#:25330415; Exp :08/26/2026 Lot#:25340169; Exp :09/05/2026 Lot#:25380387; Exp :10/17/2026 Lot#:25410936; Exp :11/13/2026 Lot#:25450649; Exp :11/30/2026 Lot#:25471328; Exp :01/05/2027 Lot#:26120385; Exp :03/27/2027 Lot#:26141494; Exp :04/07/2027 Lot#:26170183; Exp :04/21/2027 Lot#:26220497; Exp :05/28/2027

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

Class IID-0844-2026

Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

NDC00121-0653-04

Lot / batch / code informationLot#:25421159; Exp :10/21/2026 Lot#:25431644; Exp :11/03/2026 Lot#:25471687; Exp :12/02/2026 Lot#:25510930; Exp :01/05/2027 Lot#:26130247; Exp :04/17/2027 Lot#:25450648; Exp :11/30/2026 Lot#:26061716; Exp :02/28/2027 Lot#:26120384; Exp :03/27/2027 Lot#:26141493; Exp :04/07/2027 Lot#:26190055; Exp :05/04/2027 Lot#:26231530; Exp :06/05/2027

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

Class ID-0866-2026

Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 69680-166-00.

NDC69680-166-00

Lot / batch / code informationLot # 504950, Exp Date: 09/30/2026.

Recalling companyVITRUVIAS THERAPEUTICS INC

Recall initiated08/21/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Superpotent Drug

Distribution: US Nationwide.

Class IID-0843-2026

Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

NDC00121-0654-16

Lot / batch / code informationLot#:26220866; Exp :06/18/2027 Lot#:25321477; Exp :0/18/2026 Lot#:25471651; Exp :12/01/2026 Lot#:25500133; Exp :12/19/2026 Lot#:26161398; Exp :12/31/2026 Lot#:26170946; Exp :05/15/2027 Lot#:26240033; Exp :05/31/2027

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

Class IID-0842-2026

Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04

NDC00121-0653-04

Lot / batch / code informationLot #:25330169; Exp :08/25/2026 Lot #:25340107; Exp :09/04/2026 Lot #:25370044; Exp :09/30/2026 Lot #:25391430; Exp :10/30/2026 Lot #:25411035; Exp :11/13/2026 Lot #:25461036; Exp :12/12/2026 Lot #:25450206; Exp :12/12/2026 Lot #:25521269; Exp :02/03/2027 Lot #:26030426; Exp :02/09/2027 Lot #:26071765; Exp :03/11/2027 Lot #:26111371; Exp :03/24/2027 Lot #:26121435; Exp :03/31/2027 Lot #:26141209; Exp :04/07/2027 Lot #:26151211; Exp :04/13/2027 Lot #:26170561; Exp :04/23/2027 Lot #:26171144; Exp :04/24/2027 Lot #:26191168; Exp :05/08/2027 Lot #:26210307; Exp :05/21/2027 Lot #:26231182; Exp :06/04/2027 Lot #:26241285; Exp :06/15/2027

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

Class IID-0841-2026

Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16

NDC00121-0654-16

Lot / batch / code informationLot#26160463; Exp :04/20/2027 Lot#25430188; Exp :11/26/2026 Lot#25440715; Exp :12/9/2026 Lot#25501160; Exp :01/21/2027 Lot#26021054; Exp :02/5/2027 Lot#26130635; Exp :04/3/2027 Lot#26200964; Exp :05/13/2027

Recalling companySafecor Health, LLC

Recall initiated08/13/2026

StatusOngoing

Recall typeVoluntary: Firm initiated

Reason and distribution details

FDA reason: Failed Stability Specifications

Distribution: Nationwide in the USA.

ANIMAL & VETERINARY

Veterinary medication recall reports

0 reports shown

No matching reports in the latest FDA records.

This does not guarantee that no recall exists. Check the official FDA links below.

Always verify through the official FDA record.

FDA recalls and safety alertsFDA animal & veterinary recalls

Source: FDA openFDA Drug Enforcement API. Report dates may differ from the date a recall began.

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