Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
21 recalls
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Class II Ongoing
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Lots, distribution and details
- Lots / codes
- Lot # AD92721, Exp Date: 3/31/2027.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- January 27, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0342-2026
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Class III Ongoing
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Reason: Failed PH Specifications
Lots, distribution and details
- Product
- Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
- Lots / codes
- Batch XHBG; Exp. 08/31/2027
- Distribution
- Nationwide in the USA
- Quantity
- 92,376 tubes
- Recall started
- December 22, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0291-2026
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Class I Completed
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7503046054134
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Lots, distribution and details
- Lots / codes
- All Lots; All Expiration Dates.
- Distribution
- U.S. Nationwide via internet.
- Quantity
- 1,704 30-count bottles
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0493-2025
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Class I Completed
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All Lots; All Expiration Dates.
- Distribution
- U.S. Nationwide via internet.
- Quantity
- 1,342 30-count bottles
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0492-2025
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Class I Ongoing
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
Reason: Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Lots, distribution and details
- Lots / codes
- All lots, Exp. Date: 03/27/2030
- Distribution
- Nationwide within the United States
- Quantity
- 374 bottles
- Recall started
- December 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0170-2025
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Class II Ongoing
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Lots, distribution and details
- Lots / codes
- Lot#: 24183, Exp 07/01/28
- Distribution
- Product was sold via Amazon Marketplace.
- Quantity
- 321 bottles
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2025
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Class I Ongoing
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: YZM240406, Exp: 04/05/2027
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0086-2025
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Class I Ongoing
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: YZM240406, Exp: 04/05/2027
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0085-2025
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Class I Ongoing
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: 230811, Exp: 08/11/2025
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0084-2025
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Class I Ongoing
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Lots, distribution and details
- Lots / codes
- Lot #: 230811, Exp: 08/11/2025
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- November 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0083-2025
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Class II Ongoing
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Lots, distribution and details
- Lots / codes
- Lot #: IN-030, Exp. Date: NOV 2027
- Distribution
- Nationwide within the United States; additionally Canada, England, and Australia.
- Quantity
- 150
- Recall started
- November 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0042-2025
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Class II Ongoing
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
Lots, distribution and details
- Lots / codes
- All Lots
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- October 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0024-2025
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Class II Ongoing
Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dala…
Reason: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Lots, distribution and details
- Product
- Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019
- Lots / codes
- Batch # IN-032, Exp 11/30/2027
- Distribution
- Retail: South Carolina, North Carolina, Ohio; Consumer level: Nationwide within USA
- Quantity
- —
- Recall started
- June 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0666-2024
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Class I Ongoing
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Reason: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide within the U.S
- Quantity
- 57, 340 bottles
- Recall started
- July 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0626-2024
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Class I Ongoing
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All lots within Expiry
- Distribution
- Nationwide within the United States
- Quantity
- 1,331 bottles
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0620-2024
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Class II Ongoing
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
Lots, distribution and details
- Lots / codes
- Lot Number: H29585, No Expiration date
- Distribution
- US Nationwide
- Quantity
- 20 bottles
- Recall started
- May 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0558-2024
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Class I Ongoing
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Lots, distribution and details
- Lots / codes
- All lots, exp 12/12/2024
- Distribution
- USA Nationwide
- Quantity
- 300 bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0226-2024
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Class I Ongoing
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Lots, distribution and details
- Lots / codes
- All lots, exp 10/20/2024
- Distribution
- USA Nationwide
- Quantity
- —
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0225-2024
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Class I Ongoing
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
Reason: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Lots, distribution and details
- Lots / codes
- Lot 35421, exp 12/19/2025
- Distribution
- USA Nationwide
- Quantity
- 235 bottles
- Recall started
- October 20, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0224-2024
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Class II Ongoing
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Di…
Reason: Defective Delivery System
Lots, distribution and details
- Product
- Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
- Lots / codes
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
- Distribution
- Nationwide within the United States
- Quantity
- 2844 units
- Recall started
- June 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0941-2023
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Class II Ongoing
Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01
Reason: Defective container: Out of specification for container integrity leading to bottles leaking.
Lots, distribution and details
- Lots / codes
- Lot #: E1220B
- Distribution
- Distributed to 5 physician consignees located in the following states: CT, FL, and KS.
- Quantity
- 72 bottles
- Recall started
- November 29, 2021 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0278-2022
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.