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.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,222 recalls
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Class II Ongoing
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 576 containers
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0167-2026
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Class II Ongoing
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries…
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 115,994 containers
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2026
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Class II Ongoing
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 2,389 bottles
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0165-2026
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Class II Ongoing
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 2,673 tubes
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0164-2026
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Class II Ongoing
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl.…
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 7,736 tubes
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0163-2026
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Class II Ongoing
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, No…
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- 1,480 packets
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0162-2026
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Class II Ongoing
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Aven…
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Product
- DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
- Lots / codes
- All lots on or before expiry date 08/2027
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0161-2026
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Class II Ongoing
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Reason: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Lots, distribution and details
- Lots / codes
- All lots on or before expiry date 08/2027.
- Distribution
- Nationwide in the USA
- Quantity
- 3,178 bottles
- Recall started
- August 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0160-2026
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Class II Ongoing
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Lots, distribution and details
- Lots / codes
- Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26
- Distribution
- Nationwide in the USA
- Quantity
- 36,624 bottles
- Recall started
- October 23, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0159-2026
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Class II Ongoing
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporat…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90
- Lots / codes
- Lot, expiry: GS044385, exp 10/2025 ; GS044979, exp 10/2025 ; GS045797, exp 12/2025 ; GS046415, exp 12/2025 ; GS047197, exp 02/2026 ; GS047786, exp 02/2026 ; GS048477, exp 02/2026 ; GS049480, exp 03/2026 ; GS048873, exp 03/2026 ; GS049733, exp 03/2026 ; GS050224, exp 03/2026 ; GS050721, exp 03/2026 ; GS050722, exp 03/2026 ; GS051145, exp 03/2026 ; GS051726, exp 03/2026 ; GS052484, exp 03/2026 ; GS053612, exp 04/2026 ; GS054987, exp 05/2026 ; GS054409, exp 05/2026 ; GS055697, exp 05/2026 ; GS056192, exp 05/2026 ; GS056886, exp 05/2026 ; GS058077, exp 05/2026 ; GS057330, exp 05/2026
- Distribution
- Nationwide in the USA
- Quantity
- 24,869 bottles
- Recall started
- October 20, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0158-2026
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Class III Ongoing
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852,…
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
- Lots / codes
- Lot #:25JAN029, exp. date 07Nov2025; 25JAN042, exp. date 14Nov2025; 25JAN054, exp. date 21Nov2025; 25MAR021, exp. date 07Dec2025; 25APR017, exp. date 04Jan2026, 25APR025, exp. date 05Jan2026; 25MAY032, exp. date 31Jan2026; 25MAY055, exp. date 12Mar2026; 25MAY057, exp. date 14Mar2026; 25MAY073, exp. date 21Mar2026
- Distribution
- USA nationwide
- Quantity
- 67,091 bottles
- Recall started
- October 20, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0157-2026
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Class III Ongoing
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminst…
Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Lots, distribution and details
- Product
- Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
- Lots / codes
- Lot # 2405006633, Exp Date: 03/31/2026
- Distribution
- Nationwide in the USA.
- Quantity
- 4,884 30-count bottles
- Recall started
- October 10, 2025 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0156-2026
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Class II Ongoing
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
Reason: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Lots, distribution and details
- Lots / codes
- Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- October 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0155-2026
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Class II Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC,…
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots, distribution and details
- Product
- clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
- Lots / codes
- a) Lot # E403069, Exp Date: 04/2026; Lot # E406504, Exp Date: 07/2026; Lot # E309177, Exp Date: 11/2025; Lot # E400262, Exp Date: 12/2025; Lot # E404200, Exp Date: 05/2026 b) Lot # E403070, Exp Date: 04/2026; Lot # E406505, Exp Date: 07/2026; Lot # E407631, Exp Date: 08/2026; Lot # E400263, Exp Date: 12/2025; Lot # E404202, Exp Date: 05/2026 c) Lot # E403071, Exp Date: 04/2026; Lot # E407632, Exp Date: 08/2026; Lot # E405848, E405284, Exp Date: 07/2026; Lot # E400264, Exp Date: 12/2025; Lot # E404201, Exp Date: 05/2026
- Distribution
- Nationwide in the US
- Quantity
- N/A
- Recall started
- October 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0154-2026
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Class II Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar…
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots, distribution and details
- Product
- clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
- Lots / codes
- a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026
- Distribution
- Nationwide in the US
- Quantity
- N/A
- Recall started
- October 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0153-2026
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Class II Ongoing
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar…
Reason: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Lots, distribution and details
- Product
- clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
- Lots / codes
- a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025
- Distribution
- Nationwide in the US
- Quantity
- N/A
- Recall started
- October 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0152-2026
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Class II Ongoing
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva…
Reason: Subpotent drug; Clavulanate Potassium component
Lots, distribution and details
- Product
- Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
- Lots / codes
- Lot # 100062316, Exp Date: 01/2026
- Distribution
- Distributed in three (3) States: MS, OH, CA.
- Quantity
- 4680 cartons
- Recall started
- October 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0151-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.
- Lots / codes
- Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0150-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-051-88.
- Lots / codes
- Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0149-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-050-88.
- Lots / codes
- Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0148-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.
- Lots / codes
- Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0147-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
- Lots / codes
- Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0146-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
- Lots / codes
- Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0145-2026
-
Class II Ongoing
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-…
Reason: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lots, distribution and details
- Product
- Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.
- Lots / codes
- Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
- Distribution
- U.S Nationwide.
- Quantity
- N/A
- Recall started
- October 28, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0144-2026
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Class II Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.
Lots, distribution and details
- Lots / codes
- Lot # 1029921, Exp Date: 28 February 2027
- Distribution
- Distributed Nationwide in the USA.
- Quantity
- 509,360 100 mL bags
- Recall started
- October 27, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0143-2026
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 2, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.