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 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
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Class III Ongoing
Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Lots, distribution and details
- Lots / codes
- Lot #: 230346, Exp. date Aug 2025; 230090 Exp. date Feb 2025
- Distribution
- Nationwide within the United States
- Quantity
- 2466 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-0614-2024
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Class III Ongoing
Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2
Reason: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Lots, distribution and details
- Lots / codes
- Lot #: 230189, Exp. date Apr 2025; 230335, Exp. date Jul 2025; 230351, Exp. date Aug 2025
- Distribution
- Nationwide within the United States
- Quantity
- 18540 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-0613-2024
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Class II Ongoing
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775,…
Reason: Failed Dissolution Specifications: results below specifications
Lots, distribution and details
- Product
- Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
- Lots / codes
- Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024
- Distribution
- USA Nationwide
- Quantity
- a) 145,800 bottles; b) 1,368 bottles
- Recall started
- June 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0612-2024
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Class II Terminated
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03
Reason: CGMP Deviations: Out of specification for dissolution
Lots, distribution and details
- Lots / codes
- Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
- Distribution
- USA Nationwide
- Quantity
- 142 blister cards, 30 per blister card
- 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-0611-2024
-
Class II Terminated
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
Reason: Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
Lots, distribution and details
- Product
- STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
- Lots / codes
- Lot # 2550, exp. date 02-28-2026
- Distribution
- Nationwide to 60 Physician offices
- Quantity
- 31,110 x 16 fl. oz. bottle
- Recall started
- June 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0610-2024
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Class I Terminated
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Reason: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
Lots, distribution and details
- Lots / codes
- Lot # 2552, exp. date 02-28-2026
- Distribution
- Nationwide to 60 Physician offices
- Quantity
- 31,811 x 1 fl. oz. spray bottle
- Recall started
- June 5, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0609-2024
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Class II Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitone…
Reason: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Lots, distribution and details
- Product
- DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
- Lots / codes
- 24AU03024, exp. date 07/31/2025
- Distribution
- Nationwide
- Quantity
- 183 cases
- Recall started
- June 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0608-2024
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Class II Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Lots / codes
- Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0607-2024
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Class II Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
- Lots / codes
- Lot #: 17230074, 17230221, Exp Dec-31-24; 17230468, 17230479, 17230553, 17230543, 17230561, Exp Jan-31-25; 17230619, 17230624, Exp Feb-28-25; 17230879, 17230890, 17230918, 17230984, 17230996, 17231002, 17231081, Exp Mar-31-25; 17231102, 17231135, 17231329, Exp Apr-30-25; 17231369, 17231513, Exp May-31-24; 17231516, 17231713, Exp Jun-30-25; 17231909, 17231903, Exp Jul-31-25; 17231943, Exp Aug-31-25; 17232166, 17232179, Exp Sep-30-25.
- Distribution
- Nationwide
- Quantity
- —
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2024
-
Class I Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Lots / codes
- Lot #: 17221197, 17221386, 17221385, Exp May-31-24; 17221489, 17221504, 17221530, Exp Jun-30-24; 17221561, 17221579, 17221568, 17221702, 17221704, Exp Jul-31-24; 17221898, 17221993, 17222029, Exp Aug-31-24; 17222300, 17222304, 17222278, 17222609, 17222395, Exp Oct-31-24; 17222589, 17222605, 17222613, Exp Nov-30-24;
- Distribution
- Nationwide
- Quantity
- 36,630 bottles
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0605-2024
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Class I Ongoing
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-01
- Lots / codes
- Lot#: 17221446, 17221445, Exp May-31-24; 17221393, 17221403, 17221405, 17221503, 17221508, Exp Jun-30-24; 17221567, 17221566, 17221719, 17221731, Exp Jul-31-24; 17221891, 17221892, 17221900, 17221992, 17222022, Exp Aug-31-24; 17222056, 17222043, 17222068, 17222079, 17222099, 17222103, 17222114, 17222119, 17222188, 17222199, 17222209, 17222200, Exp Sep-30-24; 17222265, 17222269, Exp Oct-31-24; 17222527, 17222530, 17222583, 17222586, 17230051, 17230075, 17230067, Exp Nov-30-24;
- Distribution
- Nationwide
- Quantity
- 285,840 bottles
- Recall started
- May 30, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0604-2024
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Class II Completed
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025
- Distribution
- U.S. Nationwide
- Quantity
- 3,694 bottles
- Recall started
- April 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0603-2024
-
Class II Completed
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025
- Distribution
- U.S. Nationwide
- Quantity
- 12,691 bottles
- Recall started
- April 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0602-2024
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Class II Ongoing
Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19…
Reason: Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Lots, distribution and details
- Product
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
- Lots / codes
- Lot #s: CNSDH, Exp. 6/30/2024; CNWVM, CNWWH, Exp. 07/31/2024; CNXKW, CNXKY, CNXMB, CNXMH, Exp. 09/30/2024; CPBTP, CPBTV, Exp. 11/30/2024.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 116,144 bottles
- Recall started
- June 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0601-2024
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Class II Terminated
Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.
Reason: Presence of particulate matter: glass
Lots, distribution and details
- Lots / codes
- Lot #: L200253, L200281, L200301, Exp 07/31/2024
- Distribution
- TN
- Quantity
- 432250 vials
- Recall started
- June 27, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0600-2024
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Class II Ongoing
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Can…
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
Lots, distribution and details
- Product
- Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, L3X 2S2, Made in Canada.
- Lots / codes
- Lot# 24092009, Exp 03/27; 24094010, Exp 04/27
- Distribution
- USA nationwide.
- Quantity
- 120,319 bottles
- Recall started
- June 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0598-2024
-
Class II Terminated
Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun – 248-197, Uttarak…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun – 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
- Lots / codes
- Lot #s: 231067, 231069, Exp 04/30/2025
- Distribution
- Nationwide in the USA and Puerto rico
- Quantity
- 5752 bottles
- Recall started
- July 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0597-2024
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Class III Ongoing
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Reason: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Lots, distribution and details
- Lots / codes
- Lot #, DI2303B, Exp 12/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 868 tubes
- Recall started
- June 24, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0599-2024
-
Class III Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-…
Reason: Cross contamination with other products
Lots, distribution and details
- Product
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
- Lots / codes
- Lot #: L300217, Exp. 04/31/2025.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- n/a
- 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-0596-2024
-
Class III Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01…
Reason: Cross contamination with other products
Lots, distribution and details
- Product
- Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).
- Lots / codes
- Lot #: L300220, Exp. 05/31/2025.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 12720 vials
- 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-0595-2024
-
Class II Ongoing
Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81…
Reason: Subpotent Drug: reduced efficacy for epinephrine
Lots, distribution and details
- Product
- Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2
- Lots / codes
- Lot Number: 2311003, Expiration Date: 11/13/2024
- Distribution
- Nationwide in the USA
- Quantity
- 12,525 10 mL vials
- Recall started
- July 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0594-2024
-
Class III Ongoing
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pen…
Reason: Cross contamination with other products.
Lots, distribution and details
- Product
- Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.
- Lots / codes
- Lot L300269, Exp Date 07/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 8020 vials
- 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-0593-2024
-
Class III Ongoing
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25×2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5×2 mL Single-Dose Vial per carton, Vial NDC: 70710-…
Reason: Cross contamination with other products.
Lots, distribution and details
- Product
- Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25×2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5×2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
- Lots / codes
- Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 170,755 vials
- 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-0592-2024
-
Class II Terminated
Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc
Reason: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Lots, distribution and details
- Lots / codes
- Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
- Distribution
- Nationwide in the USA via internet sales.
- Quantity
- 90/1 oz. tubes and 248/4 oz. bottles
- 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-0591-2024
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.