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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Taro Pharmaceuticals U.S.A., Inc.: Ibuprofen Oral Suspension Recalled for Potential Plastic Particle Contamination

Agency Publication Date: October 31, 2019
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Summary

Taro Pharmaceuticals is recalling 971,667 bottles of Ibuprofen Oral Suspension (100 mg/5 mL) because small particles of inert plastic may have been introduced during the manufacturing process. The recall includes various sizes and formulations, such as 4-ounce and one-pint prescription bottles, and 4-ounce and 8-ounce berry-flavored children's versions sold under the Taro and Winco Foods brands. Consumers who have purchased these medications should check their lot numbers immediately and contact their healthcare provider or pharmacist for guidance if they have used the product.

Risk

The presence of foreign plastic particles in the liquid medication could lead to choking, irritation, or other internal injuries if swallowed. While the material is described as inert, its introduction into the medication poses a physical hazard to patients, especially children who may be more susceptible to airway obstruction or localized tissue irritation.

What You Should Do

  1. Check your medicine cabinet for Ibuprofen Oral Suspension USP (100 mg/5 mL) and Children's Ibuprofen Oral Suspension (Berry Flavor) with specific lot numbers and expiration dates.
  2. Identify the 4 fl. oz. prescription bottle (NDC 51672-1385-8) by looking for lot numbers K779030125 (Exp 10/19), D873031376 (Exp 3/20), J871233188 (Exp 9/20), L866934047 (Exp 11/20), A973134376 (12/20), or D967635229 (Exp 3/21).
  3. Identify the one-pint (473 mL) prescription bottle (NDC 51672-1385-9) by looking for lot numbers such as J78402968, J784129698, K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, A887230568, A887330568, A887430568, B865430568, B865530568, B865630568, B869530568, B869630568, D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, F865131834, G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, H865232436, H865332436, H870832436, I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, J868533164, J868633164, J868733164, J868833164, J868933164, J869033164, L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, B974034749, B974134750, B974234751, B974334752, B974434753.
  4. Identify Children's Berry Flavor Dye-Free bottles by looking for NDC 51672-2130-8 (4 oz, Lots E875131667, E875231667, J871033189, J871133189, A972934375, A973034375), NDC 51672-2130-1 (8 oz, Lot J871033187), or Winco Foods NDC 67091-321-04 (4 oz, Lot A972834374).
  5. Stop using the medication immediately if it matches the affected lot numbers and contact your healthcare provider or pharmacist for medical advice or to discuss alternatives.
  6. Return any unused portion of the recalled medication to the pharmacy or place of purchase for a refund and contact Taro Pharmaceuticals U.S.A., Inc. at 1-888-827-6872 for additional instructions.
  7. For further questions regarding consumer safety or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return to pharmacy for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ibuprofen Oral Suspension USP, 100 mg/5 mL (4 fl. oz.)
Model:
NDC 51672-1385-8
Lot Numbers:
K779030125 (Exp 10/19)
D873031376 (Exp 3/20)
J871233188 (Exp 9/20)
L866934047 (Exp 11/20)
A973134376 (Exp 12/20)
D967635229 (Exp 3/21)
Date Ranges: Expiration dates through March 2021
Product: Ibuprofen Oral Suspension USP, 100 mg/5 mL (One Pint / 473 mL)
Model:
NDC 51672-1385-9
Lot Numbers (75):
J78402968 (Exp 9/19)
J784129698 (Exp 9/19)
K765129698 (Exp 10/19)
K765229698 (Exp 10/19)
K765329698 (Exp 10/19)
K769329698 (Exp 10/19)
K778829698 (Exp 10/19)
K778929698 (Exp 10/19)
A887230568 (Exp 12/19)
A887330568 (Exp 12/19)
A887430568 (Exp 12/19)
B865430568 (Exp 1/20)
B865530568 (Exp 1/20)
B865630568 (Exp 1/20)
B869530568 (Exp 1/20)
B869630568 (Exp 1/20)
D866431198 (Exp 3/20)
D866531198 (Exp 3/20)
D866631198 (Exp 3/20)
D866731198 (Exp 3/20)
D866831198 (Exp 3/20)
D866931198 (Exp 3/20)
D872631198 (Exp 3/20)
D872731198 (Exp 3/20)
D872831198 (Exp 3/20)
D872931198 (Exp 3/20)
D873031834 (Exp 3/20)
E875331834 (Exp 4/20)
E875431834 (Exp 4/20)
E883831834 (Exp 4/20)
E883931834 (Exp 4/20)
E884031834 (Exp 4/20)
E884131834 (Exp 4/20)
F865131834 (Exp 5/20)
G879432436 (Exp 6/20)
G879532436 (Exp 6/20)
G879632436 (Exp 6/20)
G879732436 (Exp 6/20)
G879832436 (Exp 6/20)
G879932436 (Exp 6/20)
G881632436 (Exp 6/20)
G882232436 (Exp 6/20)
H865232436 (Exp 7/20)
H865332436 (Exp 7/20)
H870832436 (Exp 7/20)
I885233156 (Exp 8/20)
I885333156 (Exp 8/20)
I885433156 (Exp 8/20)
I885533156 (Exp 8/20)
I885633156 (Exp 8/20)
Date Ranges: Expiration dates through January 2021
Product: Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor (4 fl. oz.)
Model:
NDC 51672-2130-8
Lot Numbers:
E875131667 (Exp 4/20)
E875231667 (Exp 4/20)
J871033189 (Exp 9/20)
J871133189 (Exp 9/20)
A972934375 (Exp 12/20)
A973034375 (Exp 12/20)
Date Ranges: Expiration dates through December 2020
Product: Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor (8 fl. oz.)
Model:
NDC 51672-2130-1
Lot Numbers:
J871033187 (Exp 9/20)
Date Ranges: Expiration September 2020
Product: Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Distributed by Winco Foods (4 fl. oz.)
Model:
NDC 67091-321-04
Lot Numbers:
A972834374 (Exp 12/20)
Date Ranges: Expiration December 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83887
Status: Resolved
Manufacturer: Taro Pharmaceuticals U.S.A., Inc.
Sold By: Pharmacies; Winco Foods, LLC; Retail drugstores
Manufactured In: Canada
Units Affected: 5 products (138,886 bottles; 639,325 bottles; 182,986 bottles; 5,190 bottles; 5,280 bottles)
Distributed To: Nationwide
Agency Last Updated: November 5, 2019

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.