Why it was recalled
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Product description
Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
Lot numbers, UPCs & expiration codes
Lot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0298-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 138,886 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0298-2020, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83887
- Address
- 3 Skyline Dr
- Code information
- Lot #: K779030125, Exp 10/19; D873031376, Exp 3/20; J871233188, Exp 9/20; L866934047, Exp 11/20; A973134376, 12/20; D967635229, Exp 3/21
- Postal code
- 10532-2174
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0298-2020
- Classification
- Class II
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 138,886 bottles
- Termination date
- Aug 31, 2023
- Reason for recall
- Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Sep 27, 2019
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2019