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 I Terminated
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Reason: Labeling: Label Mix-up
Lots, distribution and details
- Lots / codes
- Lot # F230169A, Exp. 06/30/2025
- Distribution
- USA nationwide
- Quantity
- 4,662 bottles
- Recall started
- January 4, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0323-2024
-
Class II Ongoing
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128…
Reason: CGMP Deviations: products may not conform to the labeled specifications.
Lots, distribution and details
- Product
- Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.
- Lots / codes
- Lot #: a) 2214500032, 2216700041, 2301900118, 2312600002, 2204800002, Exp. 02/05/2024; 2306100034, 2322000078, 2322200021 02/22/2024; 2318000026, Exp 02/24/2024; 2323000070, 2324400005, 2323300016, Exp 08/29/2025; 2324800079, Exp 08/30/2025; 2325800008, Exp 09/18/2025; 2328600011, 2328600032, 10/10/2025; 2324800123, Exp 10/11/2025; 2329700005, 2329700090, Exp 10/19/2025; 2330400003, Exp 10/25/2025; 2334100101, Exp 11/13/2025; 2335300019, 2335400038, Exp 12/19/2025. b) 2212200014, Exp 02/22/2024; 2323300017, Exp 08/29/2025; 2324800124, Exp 09/18/2025. c) 2211100001, Exp 02/24/2024; 2330500009, Exp 10/25/2025; 2333200014, Exp12/19/2025.
- Distribution
- Nationwide in the US
- Quantity
- 10,103 units
- Recall started
- January 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0287-2024
-
Class II Ongoing
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.
Reason: CGMP Deviations: products may not conform to the labeled specifications.
Lots, distribution and details
- Lots / codes
- Lot #s: 2319500023, Exp: 01- 12-2024; 2330400002, Exp: 11-02-2024.
- Distribution
- Nationwide in the US
- Quantity
- 344 tubes
- Recall started
- January 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0286-2024
-
Class II Terminated
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11
Reason: Failed Impurities/Degradation Specification.
Lots, distribution and details
- Lots / codes
- Lot #: 1008111, Exp. Date 01/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 1,568 cartons
- Recall started
- January 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0285-2024
-
Class II Terminated
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
- Lots / codes
- A200817 exp 1/2024
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- Quantity
- 165,60 bottles
- Recall started
- January 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0284-2024
-
Class II Terminated
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Reason: Subpotent Drug and Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
- Lots / codes
- A200816 exp 1/2024 A201248 exp 3/2024
- Distribution
- Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
- Quantity
- 15,576 Bottles
- Recall started
- January 5, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0283-2024
-
Class I Ongoing
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 7,548 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0282-2024
-
Class I Ongoing
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-028-68.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331184, Exp. Date 02/13/2024; 2331185, Exp. Date 02/10/2024; 2331189, Exp. Date 02/20/2024; 2331191, Exp. Date 02/24/2024; 2331258,Exp. Date 03/03/2024; 2331317, Exp. Date 03/15/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 10,152 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0281-2024
-
Class I Ongoing
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-150-82.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330939, Exp. Date 01/30/2024; 2331032, Exp. Date 02/03/2024; 2331112, Exp. Date 03/19/2024; 2331190, Exp. Date 03/26/2024; 2331429, Exp. Date 04/28/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 12,564 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0280-2024
-
Class I Ongoing
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 29,016 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0279-2024
-
Class I Ongoing
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-82.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2330988, Exp. Date 01/31/2024; 2331058, Exp. Date 02/18/2024; 2331150, Exp. Date 03/10/2024; 2331231, Exp. Date 03/24/2024; 2331289, Exp. Date 03/30/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 13,920 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0278-2024
-
Class I Ongoing
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Reason: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Lots, distribution and details
- Lots / codes
- Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024.
- Distribution
- Nationwide within the United States
- Quantity
- 8,976 IV bags
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0277-2024
-
Class II Terminated
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: GS054862, Exp. Date 07/31/2025
- Distribution
- Illinois only
- Quantity
- 108 bottles
- Recall started
- January 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0276-2024
-
Class II Ongoing
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
- Lots / codes
- Lot # 100047273; Exp. 07/2025
- Distribution
- Nationwide
- Quantity
- 10,672 30-count bottles
- Recall started
- January 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0275-2024
-
Class II Terminated
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: F304833, Exp 06/2025
- Distribution
- Nationwide in the USA
- Quantity
- 4,608 Bottles
- Recall started
- January 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0274-2024
-
Class I Terminated
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Reason: Microbial Contamination of Non-Sterile Products
Lots, distribution and details
- Lots / codes
- Lot#: T08740, T08742, Exp 06/30/2026
- Distribution
- USA nationwide
- Quantity
- 21,900 bottles
- Recall started
- December 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0317-2024
-
Class I Terminated
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Reason: Microbial Contamination of Non-Sterile Products
Lots, distribution and details
- Lots / codes
- a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
- Distribution
- USA nationwide
- Quantity
- a) 31,632 bottles; b) 336,528 bottles
- Recall started
- December 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0316-2024
-
Class II Completed
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
- Lots / codes
- Lot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025.
- Distribution
- Nationwide in the USA
- Quantity
- 54,504 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0273-2024
-
Class II Completed
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Su…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
- Lots / codes
- Lot #: DNE0893A Expires 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 14,568 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0272-2024
-
Class II Completed
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, S…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
- Lots / codes
- Lot #: DNE0892A Exp. 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 1220 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0271-2024
-
Class II Completed
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
- Lots / codes
- Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 15,768 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0270-2024
-
Class II Completed
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.
- Lots / codes
- Lot #: DNE0788A Exp. 07/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 6552 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0269-2024
-
Class II Completed
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industri…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
- Lots / codes
- Lot #s: DNE0875A Exp. 01/31/2025; DNE0876A, DNE0877A, DNE1080A, DNE1081A Exp. 02/28/2025; DNE1147A, DNE1148A Exp. 03/31/2025.
- Distribution
- Nationwide in the USA
- Quantity
- 10,690 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0268-2024
-
Class II Completed
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dad…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
- Lots / codes
- Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 9,408 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0267-2024
-
Class II Completed
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadr…
Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots, distribution and details
- Product
- Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
- Lots / codes
- Lot #: DNE0620A Exp. 05/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 11,400 bottles
- Recall started
- January 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0266-2024
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 4, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.