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 Terminated
Sodium Sulfacetamide 10% – Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
Reason: Subpotent drug
Lots, distribution and details
- Lots / codes
- Lot # 22085 Exp. date 08/02/2024
- Distribution
- Nationwide in the US and Puerto Rico.
- Quantity
- 7104 Bottles
- Recall started
- April 24, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0490-2024
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Class II Terminated
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plai…
Reason: Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Lots, distribution and details
- Product
- TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
- Lots / codes
- Lots#: (a)J0732085-101023, Exp (b) B2546618-100523, Exp (c) B2546541-100523
- Distribution
- Nationwide in the USA
- Quantity
- 23,970 Tablets
- Recall started
- May 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0489-2024
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Class II Terminated
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Ph…
Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Lots, distribution and details
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
- Lots / codes
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
- Distribution
- New Jersey Only
- Quantity
- 382,104 units
- Recall started
- April 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0488-2024
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Class II Ongoing
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited…
Reason: Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Lots, distribution and details
- Product
- traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
- Lots / codes
- Lot #: 230774Hl, Exp 4/30/2026
- Distribution
- Nationwide in the USA
- Quantity
- 2,592 1000-count Bottles
- Recall started
- April 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0487-2024
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Class I Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Lots, distribution and details
- Lots / codes
- Lot # T2200352, Exp. 12/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 2402 cartons
- Recall started
- April 8, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0486-2024
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Class I Ongoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Reason: Sub-potent Drug; powder discoloration associated with decreased potency
Lots, distribution and details
- Lots / codes
- Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 17,332 cartons
- Recall started
- April 8, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0485-2024
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07…
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
- Lots / codes
- 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
- Distribution
- US Nationwide.
- Quantity
- 281,554/90 count bottles
- Recall started
- April 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0484-2024
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ…
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
- Lots / codes
- 220456: Exp. Feb 2025
- Distribution
- US Nationwide.
- Quantity
- 7,188/ 500 count bottles
- Recall started
- April 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0483-2024
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Class II Ongoing
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist…
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Lots, distribution and details
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Lots / codes
- 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
- Distribution
- US Nationwide.
- Quantity
- 281,554/90 & 1000 count bottles
- Recall started
- April 29, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0482-2024
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Class III Completed
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
Reason: Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Lots, distribution and details
- Lots / codes
- Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024
- Distribution
- Nationwide within the united states
- Quantity
- 143,230 bottles
- Recall started
- April 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0481-2024
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Class III Completed
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables…
Reason: Labeling: Wrong Barcode
Lots, distribution and details
- Product
- Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
- Lots / codes
- Lot #: CH0324001, Exp. Date 3/4/2025
- Distribution
- Nationwide within the United States
- Quantity
- 1,895 bags
- Recall started
- April 30, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0480-2024
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Class II Terminated
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-…
Reason: Lack of Assurance of Sterility: Complaints of syringe breakage
Lots, distribution and details
- Product
- EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01
- Lots / codes
- Lot # 8231500321, Exp 10/31 24; 8231500335, 8231500333, 8231500334, 8231500339, 8231500347, Exp 1/30/25
- Distribution
- USA Nationwide
- Quantity
- 251,504 syringes
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0479-2024
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Class III Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
Reason: Out of specification for assay
Lots, distribution and details
- Product
- Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
- Lots / codes
- Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
- Distribution
- Nationwide within the United States
- Quantity
- 15,414 units
- Recall started
- April 10, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0478-2024
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Class II Completed
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: BJ01922A, exp. date 03/2024
- Distribution
- US Nationwide.
- Quantity
- 2784 bottles
- Recall started
- March 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0477-2024
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Class II Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 23JUN031; Exp. 07/03/2024
- Distribution
- U.S. Nationwide
- Quantity
- 3320 bottles
- Recall started
- April 10, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0476-2024
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Class II Terminated
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Lots / codes
- lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025
- Distribution
- US Nationwide
- Quantity
- 5664 bottles
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0475-2024
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Class II Terminated
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Lots / codes
- lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
- Distribution
- US Nationwide
- Quantity
- 12808 bottles
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0474-2024
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Class II Terminated
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Lots / codes
- lot SDFC- exp. 5/31/2024 lot TFBW- exp. 5/31/2025
- Distribution
- US Nationwide
- Quantity
- 18645 tubes
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0473-2024
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Class II Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.
- Lots / codes
- Lot #: 17221312, Exp. 5/31/2024
- Distribution
- Nationwide in the USA.
- Quantity
- 3,264 bottles
- Recall started
- April 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0472-2024
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Class II Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 – 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ…
Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Lots, distribution and details
- Product
- Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 – 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
- Lots / codes
- Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
- Distribution
- USA nationwide.
- Quantity
- 59244/3ml FFS packs
- Recall started
- March 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0471-2024
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Class I Terminated
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- USA Nationwide. The product was sold via Amazon Market Place.
- Quantity
- 400 capsules
- Recall started
- February 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0470-2024
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Class III Ongoing
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Lots / codes
- Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024
- Distribution
- USA nationwide.
- Quantity
- N/A
- Recall started
- April 9, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0469-2024
-
Class III Ongoing
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Lots / codes
- Lot # AMS00223A, Exp 07/31/2025
- Distribution
- USA nationwide.
- Quantity
- N/A
- Recall started
- April 9, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0468-2024
-
Class III Ongoing
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Lots / codes
- Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
- Distribution
- USA nationwide.
- Quantity
- N/A
- Recall started
- April 9, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0467-2024
-
Class III Ongoing
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Reason: Cross Contamination with Other Products
Lots, distribution and details
- Lots / codes
- Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
- Distribution
- USA nationwide.
- Quantity
- 108,192/30 count bottles or 7 count blister packs
- Recall started
- April 9, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0466-2024
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.