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.
311 recalls
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Class II Terminated
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Lots, distribution and details
- Lots / codes
- Lot number: 243120003D, Use by Date: 03/11/2025
- Distribution
- Nationwide in the USA
- Quantity
- —
- Recall started
- December 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0174-2025
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Class II Terminated
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 77…
Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
- Lots / codes
- Lot# LA01276, Exp Date: 07/2026
- Distribution
- One US distributor in Ohio.
- Quantity
- 480 1000-count bottles
- Recall started
- December 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0167-2025
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Class II Terminated
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 m…
Reason: Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Lots, distribution and details
- Product
- Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate – 1 mg; Stannous Chloride Dihydrate – 0.D75 mg; L-Cysteine Hydrochloride Monohydrate – 1 mg; Sodium Citrate Dihydrate – 2.6 mg; Mannitol – 20 mg. The pH is adjusted to 5.6 to 5.7 with HCI or NaOH prior to lyophilization. Sealed under nitrogen. 30 Radioassay Information Labels with radiation warning symbol. 1 package insert, Rx only, Manufacture by: Curium US LLC, Maryland Heights, MO 63043, 69945-092-40
- Lots / codes
- Lot 092-24006, Catalog # N092D0, Exp 06/15/2026
- Distribution
- Nationwide USA and Canada.
- Quantity
- 5,160 vials (172 kits 30 vials/kit)
- Recall started
- November 26, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0164-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-20
- Lots / codes
- Lot #: 3115869, Exp. Date 03/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 205 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0136-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-4…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20
- Lots / codes
- Lot #: 3115924, Exp. Date 06/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 690 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0135-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-20
- Lots / codes
- Lot #: 3115448, Exp. Date 12/31/2024;3115732, Exp. Date 3/31/2025; 3116024, Exp. Date 9/30/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 1,133 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0134-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-4…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-20
- Lots / codes
- Lot #: 3115893, Exp. Date 6/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 1,664 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0133-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-20
- Lots / codes
- Lot #: 3115707, Exp. Date 02/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 988 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0132-2025
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Class II Ongoing
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442…
Reason: Subpotent and Superpotent Drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20
- Lots / codes
- Lot #: 3115936, Exp. Date 07/2025
- Distribution
- Nationwide in the USA.
- Quantity
- 2,835 cartons
- Recall started
- November 19, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0131-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 35,883 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0128-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 65,169
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0127-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Lots / codes
- Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 43,765 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0126-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Lots / codes
- Lot #: a) 8177078, Exp. Date May 2025; 8168596, Exp. Date Jan 2025 b) 3199313, Exp. Date May 2025; 3194118, Exp. Date Mar 2025; 3186238, Exp. Date Dec 2024; 3209590, Exp. Date Sep 2025; 3199317, Exp. Date May 2025; 3188733, Exp. Date Jan 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 63,077 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0125-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Lots / codes
- Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 42,331 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0124-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Lots / codes
- Lot #: a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 34,845 bottes
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0123-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 55,032 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0122-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 19, 549 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0121-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 9,828 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0120-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 118,324 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0119-2025
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Class II Ongoing
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A…
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Lots / codes
- Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025
- Distribution
- Nationwide within the United States and Puerto Rico
- Quantity
- 92,512 bottles
- Recall started
- November 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0118-2025
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Class II Terminated
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-…
Reason: Subpotent drug
Lots, distribution and details
- Product
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
- Lots / codes
- Lot #: D2300191, Exp 12/31/2025
- Distribution
- USA Nationwide
- Quantity
- —
- Recall started
- November 8, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0076-2025
-
Class II Ongoing
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Lots, distribution and details
- Lots / codes
- Lot# 34A0054, exp. date 05/07/2026
- Distribution
- USA nationwide.
- Quantity
- 587 boxes
- Recall started
- November 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0060-2025
-
Class II Ongoing
OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #ODS230001A, ODS230002A, Exp. 10/2025; ODS230003A, Exp. 11/2025.
- Distribution
- Nationwide in the US
- Quantity
- 10845 bottles
- Recall started
- October 15, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0025-2025
-
Class II Terminated
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000037436, exp. date 30-Oct-24 C274-000038893, exp. date 7-Jan-25
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 1008 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0023-2025
-
Class II Terminated
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Reason: cGMP violations
Lots, distribution and details
- Lots / codes
- Lot # C274-000038958, exp. date 17-Oct-24 C274-000039206, exp. date 23-Oct-24
- Distribution
- Product was distributed to 125 direct accounts nationwide.
- Quantity
- 753 bags
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0022-2025
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 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.