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.
15 recalls
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Class II Ongoing
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Lots, distribution and details
- Lots / codes
- Lot: 7261973A, 7261974A, Exp 01/31/2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 89592 bottles
- Recall started
- March 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0390-2026
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Class II Ongoing
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Lots, distribution and details
- Lots / codes
- All lots within expiry distributed by Gold Star Distribution.
- Distribution
- US Nationwide.
- Quantity
- Unkown
- Recall started
- December 26, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0261-2026
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Class II Ongoing
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of Ind…
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India
- Lots / codes
- Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart
- Distribution
- U.S. Nationwide
- Quantity
- N/A
- Recall started
- March 13, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0347-2025
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Class III Ongoing
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Reason: Failed Tablet/Capsule Specifications
Lots, distribution and details
- Product
- IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
- Lots / codes
- Lot #: C5406201, Exp 03/31/2028
- Distribution
- USA Nationwide
- Quantity
- 3416 botttles
- Recall started
- October 29, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0047-2025
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Class II Ongoing
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 619…
Reason: Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Lots, distribution and details
- Product
- Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
- Lots / codes
- Lot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.
- Distribution
- Nationwide in the US
- Quantity
- 1410 bottles
- Recall started
- August 9, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0041-2025
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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
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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
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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
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Class II Ongoing
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Reason: Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Lots, distribution and details
- Lots / codes
- 23140190, Exp. Date 12/31/2024
- Distribution
- Nationwide
- Quantity
- 3,288 bottles
- Recall started
- December 29, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0237-2024
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Class II Ongoing
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0999841; b) 0916071 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0566-2023
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Class II Ongoing
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Product
- Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
- Lots / codes
- SKUs 0902867 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- —
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKU 0901839 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2023
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Class II Ongoing
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Reason: CGMP deviation: product outside labeled storage temperature requirements.
Lots, distribution and details
- Lots / codes
- SKUs a) 0901458; b) 0913023; c) 0999259 stored and distributed from DCs 07/28/2022 through 03/31/2023.
- Distribution
- Nationwide within the United States
- Quantity
- Pending.
- Recall started
- March 31, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2023
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Class II Ongoing
MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS…
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU 900556;GOOD SENSE IBUPROFEN 200MG CAPLET 50 CT SKU 902333 MOTRIN CHILDREN'S BUBBLEGUM 4 FL OZ SKU 903048 GOOD SENSE IBUPROFEN REGULAR SOFTGELS 160CT SKU 999373 GOOD SENSE IBUPROFEN 200 MG CAPLET 100 CT SKU 902359 MOTRIN IB CAPLET 50 CT SKU 900604 GOOD SENSE IBUPROFEN IB CAPLET 100 CT SKU 913989 GOOD SENSE IBUPROFEN 200 MG SOFTGEL 20CT SKU 916994 ADVIL LIQUID GEL 40 CT SKU 916071 GOOD SENSE IBUPROFEN PM 200 MG 20 CT SKU 917004 ADVIL PM CAPLET 20CT SKU 913010 GOOD SENSE IBUPROFEN TABLET 100 CT SKU 913991 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Specifically:
- Lots / codes
- SKUs: 999394; 900556; 902333; 903048; 999373; 902359; 900604 913989; 916994; 916071; 917004; 913010; 913991
- Distribution
- Nationwide within the United States
- Quantity
- —
- 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-1373-2022
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.