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Drug Recalls

Last updated

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

  • Class II Ongoing

    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 6…

    Reason: Subpotent Drug

    Medline Industries, LP

    Lots, distribution and details
    Product
    Medline, Alcohol Prep Pads (2-Ply Pad, 70% Isopropyl Alcohol), 100 eaches per box, 10 boxes per case (1,000 eaches per case), Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL, 60093 USA, NDC 55329-811-30.
    Lots / codes
    Lot #: 61224040057
    Distribution
    Nationwide within the United States
    Quantity
    222,800 eaches
    Recall started
    September 29, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0035-2026
  • Class II Ongoing

    Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05

    Reason: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

    USV Private Limited · Olopatadine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: 35000409, Exp. Date 01/2026
    Distribution
    Nationwide within the United States
    Quantity
    8,952 bottles
    Recall started
    October 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0034-2026
  • Class III Ongoing

    Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Hold…

    Reason: Tablet/Capsules Imprinted with Wrong ID

    JB Chemicals and Pharmaceuticals Ltd · Cetirizine Hydrochloride

    Lots, distribution and details
    Product
    Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
    Lots / codes
    Lot # PY925014, PY925013, Exp. 1/31/2028
    Distribution
    U.S. Nationwide
    Quantity
    13,440 bottles
    Recall started
    September 12, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0033-2026
  • Class III Ongoing

    Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Hold…

    Reason: Tablet/Capsules Imprinted with Wrong ID

    JB Chemicals and Pharmaceuticals Ltd · Cetirizine Hydrochloride

    Lots, distribution and details
    Product
    Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
    Lots / codes
    Lot # PY925014A; Exp. 1/31/2028
    Distribution
    U.S. Nationwide
    Quantity
    9936 bottles
    Recall started
    September 12, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0032-2026
  • Class II Ongoing

    Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag)…

    Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    The Harvard Drug Group LLC · Gabapentin

    Lots, distribution and details
    Product
    Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
    Lots / codes
    Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    October 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0031-2026
  • Class II Ongoing

    Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

    Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    The Harvard Drug Group LLC · Gabapentin

    Lots, distribution and details
    Lots / codes
    Lot # M04950, Exp Date: 01/2026; Lot # M04989, M04990, Exp Date: 02/2026; Lot # M05056, Exp Date: 04/2026; Lot # M05150, Exp Date: 07/2026; Lot # M05290, Exp Date: 11/2026; Lot # M05312, M05342, Exp Date: 01/2027; Lot # M05369, M05386, Exp Date: 02/2027.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    October 10, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0030-2026
  • Class II Ongoing

    Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylar…

    Reason: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).

    Rising Pharma Holding, Inc. · Carbidopa

    Lots, distribution and details
    Product
    Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
    Lots / codes
    Lot # CS25070, exp. date 03/31/2027
    Distribution
    Distributed Nationwide in the USA
    Quantity
    2,064 100-count bottles
    Recall started
    October 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0029-2026
  • Class II Ongoing

    Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30

    Reason: Lack of Assurance of Sterility:

    ASTRAZENECA PHARMACEUTICALS · Benralizumab

    Lots, distribution and details
    Lots / codes
    Lot YJ0152, Expiry: 01/31/2028.
    Distribution
    Nationwide in the U.S
    Quantity
    916 pre-filled syringes
    Recall started
    October 8, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0028-2026
  • Class II Ongoing

    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10×10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 – Carton NDC [60687-695-11- Unit Dose]

    Reason: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

    Amerisource Health Services LLC · Sucralfate

    Lots, distribution and details
    Lots / codes
    Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
    Distribution
    Nationwide within the United States
    Quantity
    27,868 blister packs
    Recall started
    October 9, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0027-2026
  • Class III Ongoing

    Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91

    Reason: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

    Endo USA, Inc. · Everolimus

    Lots, distribution and details
    Lots / codes
    Lot #: 550172301, Exp. Date January 2026
    Distribution
    Nationwide within the United States
    Quantity
    1,041 cartons
    Recall started
    September 5, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0026-2026
  • Class III Ongoing

    FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

    STAQ Pharma, Inc.

    Lots, distribution and details
    Lots / codes
    Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.
    Distribution
    Nationwide in the U.S.
    Quantity
    —
    Recall started
    October 9, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0025-2026
  • Class III Ongoing

    Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

    STAQ Pharma, Inc. · Ketamine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot #: 25156673A, Expiry: 02FEB2026.
    Distribution
    Nationwide in the U.S.
    Quantity
    —
    Recall started
    October 9, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0024-2026
  • Class III Ongoing

    Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

    STAQ Pharma, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: 25104595A, Expiry: 27DEC2025.
    Distribution
    Nationwide in the U.S.
    Quantity
    —
    Recall started
    October 9, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0023-2026
  • Class II Ongoing

    Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344

    Reason: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.

    SV Labs Prescott Corporation

    Lots, distribution and details
    Lots / codes
    Lot#: 25196, Exp 2/16/2026
    Distribution
    USA Nationwide
    Quantity
    11,386 tubes
    Recall started
    September 25, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0022-2026
  • Class II Ongoing

    Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Lim…

    Reason: Failed Impurities/Degradation Specifications

    Glenmark Pharmaceuticals Inc., USA · Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol

    Lots, distribution and details
    Product
    Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
    Lots / codes
    Batch number 20230733, Exp Date: October 2025
    Distribution
    US Nationwide.
    Quantity
    26,928 packs
    Recall started
    September 3, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0021-2026
  • Class II Ongoing

    Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC · Atorvastatin Calcium

    Lots, distribution and details
    Product
    Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
    Lots / codes
    Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
    Distribution
    U.S. Nationwide
    Quantity
    —
    Recall started
    September 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0020-2026
  • Class II Ongoing

    Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC · Atorvastatin Calcium

    Lots, distribution and details
    Product
    Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
    Lots / codes
    Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026
    Distribution
    U.S. Nationwide
    Quantity
    —
    Recall started
    September 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0019-2026
  • Class II Ongoing

    Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Asc…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC · Atorvastatin Calcium

    Lots, distribution and details
    Product
    Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
    Lots / codes
    Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
    Distribution
    U.S. Nationwide
    Quantity
    —
    Recall started
    September 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0018-2026
  • Class II Ongoing

    Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, D…

    Reason: Failed Dissolution Specifications

    Ascend Laboratories, LLC · Atorvastatin Calcium

    Lots, distribution and details
    Product
    Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
    Lots / codes
    Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
    Distribution
    U.S. Nationwide
    Quantity
    141,984 bottles
    Recall started
    September 19, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0017-2026
  • Class II Ongoing

    Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.

    Reason: Discoloration

    VIONA PHARMACEUTICALS INC · Tavaborole

    Lots, distribution and details
    Lots / codes
    Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
    Distribution
    USA Nationwide
    Quantity
    13080 bottles
    Recall started
    October 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0016-2026
  • Class I Ongoing

    Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1

    Reason: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

    IntegraDose Compounding Services LLC

    Lots, distribution and details
    Product
    Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
    Lots / codes
    Lot #: 20250620OXY-1, Expiration date 10/18/2025
    Distribution
    Nationwide in the USA
    Quantity
    853/500 mL bags
    Recall started
    September 16, 2025 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0015-2026
  • Class I Ongoing

    NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

    Reason: Microbial Contamination of Sterile Products: elevated endotoxin levels

    GenoGenix LLC

    Lots, distribution and details
    Lots / codes
    Lot#: GG121624-023, within expiry
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    July 30, 2025 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0094-2026
  • Class II Ongoing

    Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

    Reason: Lack of Assurance of Sterility

    GenoGenix LLC

    Lots, distribution and details
    Lots / codes
    Lot#: GG021125-019, within expiry.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    July 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0093-2026
  • Class II Ongoing

    Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 6…

    Reason: Lack of Assurance of Sterility

    GenoGenix LLC · Tirzepatide

    Lots, distribution and details
    Product
    Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health and Synergy Wellness 60mg, 10mL vial lyophilized.
    Lots / codes
    Lots GG012925-005, GG021125-003, within expiry.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    July 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0092-2026
  • Class II Ongoing

    Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.

    Reason: Lack of Assurance of Sterility

    GenoGenix LLC

    Lots, distribution and details
    Lots / codes
    Lot#: GG021125-001, GG031125-017, within expiry.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    July 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0091-2026

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.

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