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.
3 Class I (most serious) drug recalls reported in the last 30 days.
1,094 recalls
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Class II Ongoing
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Wind…
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #: a) CFSB23001A, Exp 03/31/2025, CFSB23002A, Exp 07/31/2025; CFSB23003A, Exp 10/31/2025; CFSB23004A, Exp 10/31/2025; b) P2300196, 12/31/2024
- Distribution
- USA Nationwide
- Quantity
- 3336 bottles
- Recall started
- November 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0078-2025
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Class II Ongoing
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Win…
Reason: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
- Lots / codes
- Lot #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024
- Distribution
- USA Nationwide
- Quantity
- 102576 bottles
- Recall started
- November 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0077-2025
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Class II Terminated
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
Reason: cGMP Deviations
Lots, distribution and details
- Product
- Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
- Lots / codes
- Lot # JC101, JC102 and JC103, exp. date Oct 31, 2025
- Distribution
- Nationwide in the US
- Quantity
- 7,138 patches
- Recall started
- November 1, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0075-2025
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Class II Ongoing
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
Reason: CGMP violations.
Lots, distribution and details
- Product
- LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02
- Lots / codes
- Lot, expiry: LO09530, exp 11/3/2024; LO13412, exp 12/7/2024; LO10263, exp 1/26/2025; LO11303, exp 5/10/2025; LO12153, exp 8/3/2025; LO12483, exp 9/5/2025; LO13183, exp 11/14/2025; LO106024, exp 2/29/2026; LO108624, exp 3/26/2026; LO110224, exp 4/11/2026
- Distribution
- Product sold directly to one distributor consignee, Bob Barker Company, an American company that sells supplies to prisons, jails, and other institutions.
- Quantity
- 8,328 jugs
- 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-0074-2025
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Class II Ongoing
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
Reason: CGMP violations.
Lots, distribution and details
- Product
- LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53427-124-01
- Lots / codes
- Lot LO09530; Exp 9/5/2025
- Distribution
- Product sold directly to one distributor consignee, Bob Barker Company, an American company that sells supplies to prisons, jails, and other institutions.
- Quantity
- 5,328 sachets
- 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-0073-2025
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Class II Terminated
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 8 59424 00433 6
- Distribution
- Nationwide in the US
- Quantity
- 28,864 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0072-2025
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Class II Terminated
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 8 60006 57564 9
- Distribution
- Nationwide in the US
- Quantity
- 17,928 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0071-2025
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Class II Terminated
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 8 56294 00878 5
- Distribution
- Nationwide in the US
- Quantity
- 10,368 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0070-2025
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Class II Terminated
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- a) UPC 7 87099 48212 1 b) UPC 7 87099 48211 4
- Distribution
- Nationwide in the US
- Quantity
- 363,300 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0069-2025
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Class II Terminated
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 6 81131 07127 7
- Distribution
- Nationwide in the US
- Quantity
- 1,101,600 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0068-2025
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Class II Terminated
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- a) UPC 8 89476 41251 3 b) UPC 8 89476 41306 0
- Distribution
- Nationwide in the US
- Quantity
- 946,080 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0064-2025
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Class II Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 8 89476 41318 3, UPC 8 89476 41336 7
- Distribution
- Nationwide in the US
- Quantity
- 4,968,000 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0063-2025
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Class II Terminated
ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC 8 89476 41236 0
Reason: cGMP Deviations
Lots, distribution and details
- Lots / codes
- UPC 8 89476 41218 6, UPC 8 89476 41236 0
- Distribution
- Nationwide in the US
- Quantity
- 6,848,820 patches
- Recall started
- October 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0062-2025
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Class II Terminated
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Pack…
Reason: Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Lots, distribution and details
- Product
- Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, NDC# 68645-610-90.
- Lots / codes
- Lot #: 241103, exp. date 05/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 222, 600 bottles
- Recall started
- November 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0061-2025
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Class III Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Product
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Lots / codes
- Lot #: C5406201, Exp 03/31/2028
- Distribution
- USA Nationwide
- Quantity
- 3416 botttles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0047-2025
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Class III Terminated
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
Reason: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Lots, distribution and details
- Lots / codes
- Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025
- Distribution
- Nationwide in the US.
- Quantity
- 25814 tablets
- Recall started
- November 5, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0045-2025
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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
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 619…
Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Lots, distribution and details
- Product
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
- Lots / codes
- Lot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.
- Distribution
- Nationwide in the US
- Quantity
- 1410 bottles
- Recall started
- August 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2025
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Class II Ongoing
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Reason: Crystallization
Lots, distribution and details
- Lots / codes
- Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
- Distribution
- USA Nationwide
- Quantity
- 6048 pumps
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0038-2025
-
Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Lots, distribution and details
- Lots / codes
- Lot #: 083L051, Exp. Date: 11/2025
- Distribution
- Distributed to one Us Distributor in NJ.
- Quantity
- 155,232 bottles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0035-2025
-
Class III Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code#…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- Lots / codes
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 105,048 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0034-2025
-
Class III Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code #…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
- Lots / codes
- Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 72,648 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0033-2025
-
Class II Ongoing
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-…
Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Lots, distribution and details
- Product
- First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
- Lots / codes
- Lot, expiry: Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.
- Distribution
- Distributed to one wholesaler in OH for Nationwide distribution.
- Quantity
- 295,164 tubes
- Recall started
- September 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0013-2025
-
Class I Terminated
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Lots, distribution and details
- Lots / codes
- Lot # 2310083, Exp. 09/30/2025
- Distribution
- Nationwide in the U.S.A.
- Quantity
- 1,980 bottles
- Recall started
- September 17, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0012-2025
-
Class II Ongoing
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Reason: Crystallization
Lots, distribution and details
- Lots / codes
- Lot #: T400512, Exp 02/28/2026
- Distribution
- NY
- Quantity
- 2544 pumps
- Recall started
- September 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0011-2025
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 November 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.