Why it was recalled
Subpotent drug; Clavulanate Potassium component
Product description
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Lot numbers, UPCs & expiration codes
Lot # 100062316, Exp Date: 01/2026
Where it was sold
Distributed in three (3) States: MS, OH, CA.
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-0151-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 13, 2025
- FDA report date
- Nov 12, 2025
- Quantity
- 4680 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc
Original FDA data
Every field from FDA enforcement report D-0151-2026, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97795
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot # 100062316, Exp Date: 01/2026
- Postal code
- 07054-1120
- Report date
- Nov 12, 2025
- Product type
- Drugs
- Recall number
- D-0151-2026
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product quantity
- 4680 cartons
- Reason for recall
- Subpotent drug; Clavulanate Potassium component
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
- Distribution pattern
- Distributed in three (3) States: MS, OH, CA.
- Recall initiation date
- Oct 13, 2025
- Initial firm notification
- Letter
- Center classification date
- Nov 3, 2025