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 Completed
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Lots / codes
- Lot #: 220128, Exp. Date 12/2024
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 7,107 bottles
- Recall started
- October 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0009-2025
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Class II Ongoing
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5/31/25; 23122325, 23122329, 23122330, 23122331, Exp Date 6/30/26; 23122776, 23122852, 23122853, 23123154, 23123155, Exp Date 8/31/26; 23123458, Exp Date 9/30/26.
- Distribution
- Nationwide in the USA and PR
- Quantity
- 117,493 bottles
- Recall started
- September 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0668-2024
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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
-
Class II Ongoing
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lots, distribution and details
- Product
- Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
- Lots / codes
- Lot: 387489, Exp. Oct 24; 387490, Exp. Jun 25; 390422, Exp. Nov 24; 390424, Exp. Oct 24; 391692, Exp. Jun 25; 391893, Exp. Nov 25; 394822, Exp. Feb 26; 395991, Exp. Mar 26; 397905, 397973, 397974, Exp May 26; 399019, 399254, Exp. Jun 26; 399922, Exp. Jul 26; 408738, Exp. Mar 27; T3911, Exp. Sep 24; T4015, T4031, T4032, T4033, T4108, Exp. Oct 24.
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Quantity
- 763,426 tubes
- Recall started
- September 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0665-2024
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Class II Ongoing
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lots, distribution and details
- Product
- Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
- Lots / codes
- Lot: 387392, 387393, 387394, Exp. Feb 25; 387395, 388729, 388730, 388731, 388732, 390391, 390404, Exp. Apr 25; 391688, 391734, Exp. Oct 25; 392616, 392620, Exp. Dec 25; 392987, 393560, Exp. Jan 26; 394816, 394821, Exp. Nov 25; 394927, 394929, Exp. Feb 26; 395713, 395992, 396815, Exp. Mar 26; 396816, 397248, 397315, Exp. Apr 26; 397316, 397774, 397775, 397776, 398436, 398437, Exp. May 26; 398621, 398643, 398739, 398944, 399001, 399255, 399270, 399271, Exp. Jun 26; 399798, 399806, 400003, Exp. Jul 26; 408668, 408723, 408737, 408853, 408895, Exp. Apr 27; 409121, 409142, Exp. May 27; 409261, Exp. Apr 27; T4534, T4535, T4591, T4592, Exp. Dec 24; T4660, T4661, T4696, T4697, T4709, T4772, T4773, Exp. Jan 25; T4844, T4845, Feb 25
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Quantity
- 2,473,563 tubes
- Recall started
- September 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0664-2024
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Class III Ongoing
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Reason: Discoloration
Lots, distribution and details
- Product
- AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
- Lots / codes
- Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
- Distribution
- Nationwide in the US
- Quantity
- 3,984 bottles
- Recall started
- August 24, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0659-2024
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Class II Ongoing
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
Reason: Microbial contamination of non-sterile Products –
Lots, distribution and details
- Lots / codes
- Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026
- Distribution
- Distributed nationwide in USA and on line
- Quantity
- 30,946 tubes
- Recall started
- August 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0657-2024
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Class II Ongoing
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Reason: Failed Impurities/Degradation Specifications – at 18-month Stability testing
Lots, distribution and details
- Lots / codes
- Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
- Distribution
- CA and NV
- Quantity
- 266 bottles
- Recall started
- August 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2024
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Class II Ongoing
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 – 100 Tablets per bottle, b) NDC 55111-682-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 14940 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0646-2024
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Class II Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 – 100 Tablets per bottle, b)NDC 5511-683-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 31,802 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Product
- IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
- Lots / codes
- a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 103,298 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0644-2024
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Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising…
Reason: Defective Container: patients are 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
- Product
- Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
- Lots / codes
- Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
- Distribution
- Nationwide U.S.A.
- Quantity
- 176,784 bottles
- Recall started
- August 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0642-2024
-
Class I Ongoing
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-…
Reason: Labeling: Missing Label – some bottles are missing the the manufacturers label that includes the drug facts information.
Lots, distribution and details
- Product
- Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
- Lots / codes
- Lot#: AC2523005A, Exp 6/30/2025
- Distribution
- NJ, NY & PA
- Quantity
- 240 bottles
- Recall started
- July 11, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0641-2024
-
Class I Ongoing
Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkel…
Reason: Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Lots, distribution and details
- Product
- Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
- Lots / codes
- Lot #24070381; Exp. 09/30/2025
- Distribution
- OH and PR
- Quantity
- 31,400 bags
- Recall started
- July 8, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0635-2024
-
Class III Completed
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC…
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots, distribution and details
- Product
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
- Lots / codes
- Lot # AD12890, Exp 09/30/2024
- Distribution
- Product was distributed to one distributor
- Quantity
- 96 vials
- Recall started
- August 7, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0633-2024
-
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; yellow colored spike from cap lodged in the nozzle
Lots, distribution and details
- Product
- 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].
- Lots / codes
- Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
- Distribution
- Nationwide in the US
- Quantity
- 362,544 bottles
- Recall started
- July 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0632-2024
-
Class III Completed
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Reason: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Lots, distribution and details
- Lots / codes
- Lot # BB29124, Exp. 02/28/2026
- Distribution
- Nationwide in the USA
- Quantity
- 12,624 bottles
- Recall started
- August 1, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0629-2024
-
Class III Terminated
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuti…
Reason: Defective container: potential for non-sealed pouches which can lead to product leakage.
Lots, distribution and details
- Product
- PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
- Lots / codes
- Lot #S300542, exp. date June 30, 2025
- Distribution
- Nationwide in the US.
- Quantity
- 13,200 cartons
- Recall started
- July 2, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0628-2024
-
Class III Terminated
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 6…
Reason: Label mix-up: Carton incorrectly labeled.
Lots, distribution and details
- Product
- Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
- Lots / codes
- Lot #: 31670346AA, Exp 12/31/2026
- Distribution
- Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
- Quantity
- 21,192 Bottles
- Recall started
- July 18, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0627-2024
-
Class III Ongoing
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Lots, distribution and details
- Lots / codes
- Lot #: T2305999, Exp. Date 11/2025
- Distribution
- Nationwide within the United States
- Quantity
- 5,136 cartons
- Recall started
- June 26, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0625-2024
-
Class II Ongoing
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited…
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
- Product
- Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
- Lots / codes
- Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
- Distribution
- U.S. A. Nationwide
- Quantity
- 66,528 bottles
- Recall started
- July 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0623-2024
-
Class I Terminated
Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Lots, distribution and details
- Lots / codes
- Lot 550147301, Exp. 08/31/2026
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 8,139 cartons
- Recall started
- July 10, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0622-2024
-
Class I Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2,…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
- Lots / codes
- [100 count bottles]: Lot 17221738, Exp 07/31/2024; Lot 17222494, Exp 10/31/2024; Lot 17230533, Exp 01/31/2025; Lot 17232208, Exp 09/30/2025; [500 count bottles]: Lot 17221823, Lot 17221830, Exp 07/31/2024; Lot 17221831, Exp 08/31/2024; Lot 17230248, Lot 17230253, Lot 17230271, Exp 12/31/2024; Lot 17230796, Lot 17230820, Exp 02/28/2025; Lot 17230825, Lot 17230833, Lot 17230840, Exp 03/31/2025; Lot 17231537, Lot 17231540, Lot 17231719, Lot 17231737, Exp 06/30/2025; Lot 17232111, Lot 17232164, Exp 09/30/2025
- Distribution
- US Nationwide.
- Quantity
- 61,231 bottles
- Recall started
- June 25, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0619-2024
-
Class III Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Lots, distribution and details
- Product
- Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7
- Lots / codes
- Lot #: 220365, Exp date Oct 2024 ; 230090, Exp. date Feb 2025
- Distribution
- Nationwide within the United States
- Quantity
- 2082 bottles
- Recall started
- June 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0616-2024
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Class III Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Lots, distribution and details
- Product
- Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0
- Lots / codes
- Lot #: 220364, Exp. date Oct 2024; 230424, Exp. date Sep 2025
- Distribution
- Nationwide within the United States
- Quantity
- 11130 bottles
- Recall started
- June 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0615-2024
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.