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.
3,250 recalls
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Class II Completed
HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4×1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon…
Reason: CGMP Deviations: sterile water not used for production
Lots, distribution and details
- Product
- HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4×1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210
- Lots / codes
- Lot #: a) 41320, Exp. Date 7/27/2024; 41020, Exp. Date 8/9/2024; BC06614, Exp. Date 8/15/2024; BCT07768, Exp. Date 9/23/2024; BCT09410, Exp. Date 11/17/2024; CCT02139, Exp. Date 3/10/2025; CCT01561, Exp. Date 3/15/2025; CCT02953, Exp. Date 4/10/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT07274, Exp. Date 8/24/2025; CCT09516, Exp. Date 11/1/2025; CCT10500, Exp. Date 12/5/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT03947, Exp. Date 4/30/2026; DCT04406, Exp. Date 5/24/2026; CCT01651, Exp. Date 2/21/2025 b) CCT03654, Exp. Date 5/11/2025 c) BCT07768, Exp. Date 9/23/2024; BCT07975, Exp. Date 9/29/2024; BCT09410, Exp. Date 11/17/2024; BCT10246, Exp. Date 12/20/2024; CCT00705, Exp. Date 1/23/2025; CCT01952, Exp. Date 3/3/2025; CCT02139, Exp. Date 3/10/2025; CCT02689, Exp. Date 3/30/2025; CCT02346, Exp. Date 4/21/2025; CCT03654, Exp. Date 5/11/2025; CCT04010, Exp. Date 5/17/2025; CCT04630, Exp. Date 6/6/2025; CCT05946, Exp. Date 7/17/2025; CCT06785, Exp. Date 8/10/2025; CCT07274, Exp. Date 8/24/2025; CCT08515, Exp. Date 10/2/2025; CCT08936, Exp. Date 10/13/2025; CCT09516, Exp. Date 11/1/2025; CCT10888, Exp. Date 12/18/2025; DCT01157, Exp. Date 2/1/2026; DCT01586, Exp. Date 2/14/2026; DCT02902, Exp. Date 3/27/2026; DCT03947, Exp. Date 4/30/2026; CCT01952, Exp. Date 3/3/2025; d) BC06614, Exp. Date 8/15/2024; CCT00705, Exp. Date 1/23/2025; CCT06785, Exp. Date 8/10/2025; CCT10500, Exp. Date 12/5/2025; DCT01586, Exp. Date 2/14/2026
- Distribution
- Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
- Quantity
- —
- Recall started
- August 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0640-2024
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Class II Completed
Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN…
Reason: CGMP Deviations: sterile water not used for production
Lots, distribution and details
- Product
- Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.
- Lots / codes
- Lot #: a) BC05977, Exp. Date 08/05/2024; B06664, Exp. Date 08/17/2024, B06664, Exp. Date 08/17/2024; b) B06664, Exp. Date 08/17/2024; BC06867, Exp. Date 10/03/2024; BC06867, Exp. Date 10/03/2024; BCT08309, Exp. Date 10/11/2024; BK06696, Exp. Date 08/17/2024; CCT01774, Exp. Date 02/24/2025; CCT03579, Exp. Date 05/01/2025; CKM06510, Exp. Date 08/02/2025; DCT04332, Exp. Date 05/17/2026
- Distribution
- Nationwide within the United States and Toronto, Canada (Rubbing alcohol)
- Quantity
- 604
- Recall started
- August 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0639-2024
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Class I Ongoing
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Reason: Presence of Particulate Matter
Lots, distribution and details
- Lots / codes
- Lot #: J2L763, J2L764, Exp: 31 March 2025
- Distribution
- Nationwide within U.S.A
- Quantity
- 63,444 containers
- Recall started
- July 24, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0638-2024
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Class II Ongoing
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Reason: Superpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 100042386, Exp. Date 06/2025
- Distribution
- Product was distributed nationwide within the United States
- Quantity
- 7,080 unit dose packets
- 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-0637-2024
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Class II Ongoing
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: C274-000037397, C274-000037398, C274-000037399, C274-000037400, Exp. Date 10/14/2024.
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- August 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0636-2024
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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
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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
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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
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Class II Terminated
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
Reason: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Lots, distribution and details
- Lots / codes
- Lot 1380040A, Exp. date July 31, 2025
- Distribution
- Nationwide in the USA
- Quantity
- 11,808 500-count Bottles
- Recall started
- July 31, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0634-2024
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Class I Terminated
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Reason: Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Lots, distribution and details
- Lots / codes
- Lot: 4138197; Exp 10/31/2025
- Distribution
- Nationwide within the United States.
- Quantity
- 429 bottles
- Recall started
- June 21, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0631-2024
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Class II Terminated
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 179338, Beyond use date: 08/14/2024
- Distribution
- Nationwide within the United States
- Quantity
- 2,797
- Recall started
- August 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0630-2024
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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
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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
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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
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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 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
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Class II Ongoing
Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.
Reason: Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Lots, distribution and details
- Lots / codes
- Lot #: CPR230029A
- Distribution
- Nationwide in the USA
- Quantity
- 17136 vials
- Recall started
- July 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0624-2024
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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
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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
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Class II Ongoing
Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 6846…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.
- Lots / codes
- Lot# 19241453; Exp MARCH 2026
- Distribution
- U.S. Nationwide
- Quantity
- 14,004 cartons
- Recall started
- July 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0621-2024
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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 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 Terminated
Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.
Reason: Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Lots, distribution and details
- Lots / codes
- lot #: 32093, Exp. 8/31/2028
- Distribution
- Nationwide in the USA
- Quantity
- 11 kits
- Recall started
- May 31, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0618-2024
-
Class II Terminated
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India;…
Reason: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Lots, distribution and details
- Product
- Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
- Lots / codes
- Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024
- Distribution
- Nationwide within the United States
- Quantity
- a) 13,128 bottles; b) 252 bottles
- Recall started
- June 21, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0617-2024
-
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
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.