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.
64 recalls
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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
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Class III Ongoing
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
Reason: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Lots, distribution and details
- Lots / codes
- Lot # 1187435 exp date: 02/2024
- Distribution
- Distributed in the US. No government or foreign consignees.
- Quantity
- 864 cartons
- Recall started
- October 17, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0088-2024
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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.