Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lots, distribution and details
- Product
- Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
- Lots / codes
- Lot: 387489, Exp. Oct 24; 387490, Exp. Jun 25; 390422, Exp. Nov 24; 390424, Exp. Oct 24; 391692, Exp. Jun 25; 391893, Exp. Nov 25; 394822, Exp. Feb 26; 395991, Exp. Mar 26; 397905, 397973, 397974, Exp May 26; 399019, 399254, Exp. Jun 26; 399922, Exp. Jul 26; 408738, Exp. Mar 27; T3911, Exp. Sep 24; T4015, T4031, T4032, T4033, T4108, Exp. Oct 24.
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Quantity
- 763,426 tubes
- Recall started
- September 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0665-2024
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Class II Ongoing
Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Lots, distribution and details
- Product
- Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
- Lots / codes
- Lot: 387392, 387393, 387394, Exp. Feb 25; 387395, 388729, 388730, 388731, 388732, 390391, 390404, Exp. Apr 25; 391688, 391734, Exp. Oct 25; 392616, 392620, Exp. Dec 25; 392987, 393560, Exp. Jan 26; 394816, 394821, Exp. Nov 25; 394927, 394929, Exp. Feb 26; 395713, 395992, 396815, Exp. Mar 26; 396816, 397248, 397315, Exp. Apr 26; 397316, 397774, 397775, 397776, 398436, 398437, Exp. May 26; 398621, 398643, 398739, 398944, 399001, 399255, 399270, 399271, Exp. Jun 26; 399798, 399806, 400003, Exp. Jul 26; 408668, 408723, 408737, 408853, 408895, Exp. Apr 27; 409121, 409142, Exp. May 27; 409261, Exp. Apr 27; T4534, T4535, T4591, T4592, Exp. Dec 24; T4660, T4661, T4696, T4697, T4709, T4772, T4773, Exp. Jan 25; T4844, T4845, Feb 25
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Quantity
- 2,473,563 tubes
- Recall started
- September 16, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0664-2024
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Class II Terminated
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Product lot number: 609763 Beyond Use Date: 04/18/2025
- Distribution
- Nationwide
- Quantity
- 450
- Recall started
- September 5, 2024 ()
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0663-2024
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Class II Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919…
Reason: Microbial Contamination of Non-Sterile Product
Lots, distribution and details
- Product
- Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R
- Lots / codes
- Lot #: 91771, Exp. Date 09/2025
- Distribution
- Nationwide within the United States
- Quantity
- 3476 units
- Recall started
- September 3, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0662-2024
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Class II Terminated
Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Reason: Temperature abuse: Products exposed to improper temperature above drug label specifications.
Lots, distribution and details
- Lots / codes
- Lot # 476261, 479751, 479741, Exp 3/31/2026
- Distribution
- Product was distributed to two medical facilities in MD and VA.
- Quantity
- 27 bottles
- Recall started
- September 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0661-2024
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Class II Completed
Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #: 19223615, 19223537, 19223544,19223568, 19223593,19223641, Exp. Date 08/2024; 19224055,19224281, 19224307, 19224321, 19224341, 19224467, Exp. Date 09/2024; 19224525, 19224542, 19224560,19224580, Exp. Date 10/2024; 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, 19225401, Exp. Date 11/2024; 19230115, 19230123, 19230132, 19230137, 19230167, 19230170, Exp. Date 12/2024; 19230572, 19230607, 19230614, 19230628, 19230631, Exp. Date 1/2025; 19230874, 19230925,19230941, 19230957, 19230976,19231232, 19231238, 19231282,19231285, Exp. Date 02/2025.
- Distribution
- Product was distributed nationwide within the United States.
- Quantity
- 2,031,480 ointments
- Recall started
- August 30, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0660-2024
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Class III Ongoing
AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Reason: Discoloration
Lots, distribution and details
- Product
- AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
- Lots / codes
- Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
- Distribution
- Nationwide in the US
- Quantity
- 3,984 bottles
- Recall started
- August 24, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0659-2024
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Class III Terminated
Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511…
Reason: LABELING: LABEL MIX-UP.
Lots, distribution and details
- Product
- Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1
- Lots / codes
- Lot #G073DC, Exp 3/31/2026
- Distribution
- 120 direct customers, Nationwide US. No foreign, DOD/VA.
- Quantity
- —
- Recall started
- August 20, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0658-2024
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Class II Ongoing
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
Reason: Microbial contamination of non-sterile Products –
Lots, distribution and details
- Lots / codes
- Lot: X4054A, Exp: 2/2026; X4136A, X4137A, X4138A, Exp: 5/2026
- Distribution
- Distributed nationwide in USA and on line
- Quantity
- 30,946 tubes
- Recall started
- August 28, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0657-2024
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Class II Ongoing
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
- Lots / codes
- Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
- Distribution
- Nationwide in the USA
- Quantity
- 1,732 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0656-2024
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Class II Ongoing
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
- Lots / codes
- Lot # ProRx051424, BUD 11/13/2024
- Distribution
- Nationwide in the USA
- Quantity
- 1,489 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0655-2024
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Class II Ongoing
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
- Lots / codes
- Lot # ProRx031924-1, BUD 09/18/2024
- Distribution
- Nationwide in the USA
- Quantity
- 500 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0654-2024
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Class II Ongoing
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- ProRx061424, BUD 12/13/2024
- Distribution
- Nationwide in the USA
- Quantity
- 1,960 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0653-2024
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Class II Ongoing
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024
- Distribution
- Nationwide in the USA
- Quantity
- 8,396 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0652-2024
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Class II Ongoing
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot # ProRx040924-1, BUD 10/08/2024
- Distribution
- Nationwide in the USA
- Quantity
- 37 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0651-2024
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Class II Ongoing
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
- Lots / codes
- Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024
- Distribution
- Nationwide in the USA
- Quantity
- 2,490 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0650-2024
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Class I Ongoing
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Lots, distribution and details
- Product
- Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
- Lots / codes
- Lot # N008235, Exp 8/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 44,208 containers
- Recall started
- August 1, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0649-2024
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Class II Terminated
Cefixime for Oral Suspension USP, 100 mg/5 mL, 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: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Lots, distribution and details
- Lots / codes
- Lot #: F201517, Exp 11/30/2024
- Distribution
- USA nationwide.
- Quantity
- 4554 bottles
- Recall started
- August 21, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0648-2024
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Class II Ongoing
Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.
Reason: Failed Impurities/Degradation Specifications – at 18-month Stability testing
Lots, distribution and details
- Lots / codes
- Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.
- Distribution
- CA and NV
- Quantity
- 266 bottles
- Recall started
- August 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0647-2024
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Class II Ongoing
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 – 100 Tablets per bottle, b) NDC 55111-682-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 14940 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0646-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 – 100 Tablets per bottle, b)NDC 5511-683-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Lots / codes
- a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 31,802 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0645-2024
-
Class II Ongoing
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
Reason: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Lots, distribution and details
- Product
- IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 – 100 Tablets per bottle, b)NDC 55111-684-05 – 500 Tablets per bottle.
- Lots / codes
- a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 103,298 bottles
- Recall started
- August 6, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0644-2024
-
Class II Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phas…
Reason: Failed Dissolution Specifications: below specification results
Lots, distribution and details
- Product
- Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh – 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Lots / codes
- Lot#: 17240105, Exp 12/31/2025
- Distribution
- Nationwide USA
- Quantity
- 2404 bottles
- Recall started
- July 31, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0643-2024
-
Class II Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising…
Reason: Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Lots, distribution and details
- Product
- Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
- Lots / codes
- Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
- Distribution
- Nationwide U.S.A.
- Quantity
- 176,784 bottles
- Recall started
- August 12, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0642-2024
-
Class I Ongoing
Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-…
Reason: Labeling: Missing Label – some bottles are missing the the manufacturers label that includes the drug facts information.
Lots, distribution and details
- Product
- Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
- Lots / codes
- Lot#: AC2523005A, Exp 6/30/2025
- Distribution
- NJ, NY & PA
- Quantity
- 240 bottles
- Recall started
- July 11, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0641-2024
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.