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.
12 recalls
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Class II Ongoing
Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally – 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Caym…
Reason: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Lots, distribution and details
- Product
- Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally – 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-10
- Lots / codes
- Lot: C2403017, Exp 12/31/2026
- Distribution
- USA Nationwide
- Quantity
- 1476 bottles
- Recall started
- June 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0525-2025
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Class I Completed
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7 503046 054295
Reason: Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All Lots; All Expiration Dates.
- Distribution
- U.S. Nationwide via internet.
- Quantity
- 1,342 30-count bottles
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0492-2025
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Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
- Lots / codes
- Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 22,152 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0443-2025
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Class II Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA)…
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
- Lots / codes
- Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
- Distribution
- Nationwide -in the USA
- Quantity
- 30,674 30 sachets/carton
- Recall started
- May 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0442-2025
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Class II Ongoing
UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323
Reason: cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Lots, distribution and details
- Lots / codes
- Lot#: 24183, Exp 07/01/28
- Distribution
- Product was sold via Amazon Marketplace.
- Quantity
- 321 bottles
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0166-2025
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Class III Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington,…
Reason: Labeling: Not Elsewhere Classified – Wrong NDC number
Lots, distribution and details
- Product
- Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
- Lots / codes
- Lot#: M408002, Exp 05/31/2026
- Distribution
- USA Nationwide.
- Quantity
- 4404 packs
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0102-2025
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Class I Ongoing
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Reason: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- Nationwide within the U.S
- Quantity
- 57, 340 bottles
- Recall started
- July 18, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0626-2024
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Class I Ongoing
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Lots, distribution and details
- Lots / codes
- All lots within Expiry
- Distribution
- Nationwide within the United States
- Quantity
- 1,331 bottles
- Recall started
- July 12, 2024 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0620-2024
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Class II Completed
Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2…
Reason: Subpotent Drug: Out of specification for assay
Lots, distribution and details
- Product
- Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
- Lots / codes
- Lot #0013R; Exp. 01/2026
- Distribution
- Nationwide
- Quantity
- 3,600 cartons
- Recall started
- February 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0355-2024
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Class III Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwa…
Reason: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
Lots, distribution and details
- Product
- Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
- Lots / codes
- Lot # 17220002, Exp Date 11/30/2023
- Distribution
- Nationwide in the USA
- Quantity
- 8,448 30-count bottles, 168 1000-count bottles
- Recall started
- October 23, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0112-2024
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Class II Ongoing
GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKU: 999850
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1418-2022
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Class II Ongoing
GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 900055; 914128
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1417-2022
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.