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.
183 recalls
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Class III Ongoing
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Reason: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Lots, distribution and details
- Product
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
- Lots / codes
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Distribution
- Nationwide within the U.S
- Quantity
- 403,200 tablets
- Recall started
- August 25, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0836-2026
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Class III Ongoing
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
- Distribution
- USA Nationwide
- Quantity
- 772 bottles
- Recall started
- August 24, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0835-2026
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Class I Ongoing
Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204…
Reason: Microbial Contamination of Sterile Products – out of specifications results were obtained for bacterial endotoxin.
Lots, distribution and details
- Product
- Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090
- Lots / codes
- Lot#: LG342009076, Beyond Use Date: 10/4/26
- Distribution
- USA Nationwide.
- Quantity
- 53 vials
- Recall started
- August 5, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0851-2026
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Class I Ongoing
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
Reason: Presence of particulate matter: Particulates identified as fiberglass
Lots, distribution and details
- Lots / codes
- Lot: Y495523, Y495523A, Exp 31-Oct-2027
- Distribution
- Natonwide in the USA
- Quantity
- 145,464 500mL bags
- Recall started
- August 17, 2026 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0849-2026
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Class II Ongoing
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Reason: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Lots, distribution and details
- Lots / codes
- Lot # GS062298, Exp Date: 09/30/ 2026.
- Distribution
- US Nationwide.
- Quantity
- 6791 30-count bottles
- Recall started
- August 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0847-2026
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Class III Ongoing
Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3×10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
Reason: Labeling: Label Mix-up
Lots, distribution and details
- Lots / codes
- Lot # 1030023, Exp Date: 06/30/2027.
- Distribution
- US Nationwide.
- Quantity
- 10,953 cartons.
- Recall started
- August 19, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0840-2026
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Class II Ongoing
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Lots, distribution and details
- Lots / codes
- Lot #: 3225272, Exp. September 30, 2026
- Distribution
- Nationwide within the U.S
- Quantity
- 47,662 bottles
- Recall started
- August 17, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0839-2026
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Class III Ongoing
Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Lots, distribution and details
- Product
- Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
- Lots / codes
- Lot#: 1221973, Exp 3/24/2027
- Distribution
- MO, TN
- Quantity
- 3,002 vials
- Recall started
- August 19, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0838-2026
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Class II Ongoing
2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Product
- 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
- Lots / codes
- Lot 108491 with case sequence numbers 14841 through 20013.
- Distribution
- US Nationwide.
- Quantity
- 165,536 packages
- Recall started
- August 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0837-2026
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Class II Ongoing
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot: 1394026, Exp. 02/2028.
- Distribution
- U.S. Nationwide
- Quantity
- 175,392 bottles
- Recall started
- August 24, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0834-2026
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Class III Ongoing
Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 2085…
Reason: Failed dissolution specifications.
Lots, distribution and details
- Product
- Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.
- Lots / codes
- Lot# 2145283, Exp Date: 31-Mar-2030.
- Distribution
- US Nationwide.
- Quantity
- 11304 bottles
- Recall started
- August 31, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0833-2026
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Class II Ongoing
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: My…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
- Lots / codes
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Distribution
- U.S. Nationwide
- Quantity
- 11,336 units
- Recall started
- August 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0830-2026
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Class II Ongoing
Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
Reason: CGMP Deviations: Potential contamination of raw material
Lots, distribution and details
- Lots / codes
- Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
- Distribution
- Distributed in the state of Colorado (US).
- Quantity
- 1,200 4 oz-Jar
- Recall started
- August 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0829-2026
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Class II Ongoing
Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
Reason: CGMP Deviations: Potential contamination of raw material
Lots, distribution and details
- Product
- Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
- Lots / codes
- Lot #: T1110, Exp: 1/7/2027; T1111, Exp: 1/9/2027; T1112, Exp: 1/16/2027; T1113, Exp: 1/17/2027; T1114, Exp: 1/17/2027
- Distribution
- Distributed in the state of Colorado (US).
- Quantity
- 2,400 2 oz-jars
- Recall started
- August 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0828-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml – 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Lots / codes
- Lots: G23W03B, Exp. 8/4/2027; A16X02, Exp. 1/20/2029: A16X03, Exp. 1/22/2029.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 2,149 90mL-Tubes
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0826-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml – 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 0747…
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml – 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733
- Lots / codes
- Lots: H22V02A, Exp. 8/30/2026; C13W01B, Exp. 3/27/2027; C24W01, Exp. 4/28/2027; G23W02, Exp. 7/25/2027; G23W01B, Exp. 7/24/2027; K10W02, Exp. 10/21/2028.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 23,941, 20mL-Tube
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0825-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml – 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.…
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Product
- THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml – 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293
- Lots / codes
- Lots: C13W01A, Exp. 3/27/2027; G23W01A, Exp. 7/24/2027; M04W01, Exp. 12/10/2028.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 27,492 3mL Sachets
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0824-2026
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Class II Ongoing
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML – 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Lots, distribution and details
- Lots / codes
- Lots: H22V01 Exp. 8/29/2026, H22V02 Exp. 8/30/2026, K22V02A Exp. 10/29/2026, M10V01 Exp. 01/21/2027, G23W02B Exp. 7/25/2027, G23W03 Exp. 8/4/2027, G23W03D Exp. 8/4/2027, K10W01A Exp. 10/17/2028, K10W01C Exp. 10/17/2028, M11W02 12/17/2028, F09X02 Exp. 6/17/2029.
- Distribution
- Nationwide within the U.S.A
- Quantity
- 29,014 50mL Tubes
- Recall started
- August 14, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0823-2026
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Class III Ongoing
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Lot # DMA25006, Exp Date: 11/30/2028.
- Distribution
- US Nationwide.
- Quantity
- 14,232 bottles (1,423,200 tablets)
- Recall started
- August 7, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0822-2026
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Class II Ongoing
Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12.
- Lots / codes
- Lot # NC193856, Exp Date: 04/18/2028.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0821-2026
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Class II Ongoing
Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # NC193894, Exp Date: 04/25/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0820-2026
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Class II Ongoing
Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot # NC185448, Exp Date: 8/31/2027; Lot # NC192910, Exp Date: 4/30/2028; Lot # NC195218, Exp Date: 6/30/2028.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0819-2026
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Class II Ongoing
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-995-24.
- Lots / codes
- Lot # NC194068, Exp Date: 10/29/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0818-2026
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Class II Ongoing
Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50.
- Lots / codes
- Lot # NC194075, Exp Date: 10/29/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0817-2026
-
Class II Ongoing
Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-95…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50.
- Lots / codes
- Lot # NC193689, Exp Date: 10/16/2027.
- Distribution
- US Nationwide; Puerto Rico; and Chile.
- Quantity
- N/A
- Recall started
- August 6, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0816-2026
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.