Why it was recalled
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Product description
Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.
Lot numbers, UPCs & expiration codes
All lots within expiry
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0863-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 13, 2017
- FDA report date
- May 31, 2017
- Quantity
- 10,263,585 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Standard Homeopathic Company
Original FDA data
Every field from FDA enforcement report D-0863-2017, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 77009
- Address
- 154 W 131st St
- Code information
- All lots within expiry
- Postal code
- 90061-1616
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0863-2017
- Classification
- Class I
- Recalling firm
- Standard Homeopathic Company
- Product quantity
- 10,263,585 bottles
- Termination date
- Oct 26, 2017
- Reason for recall
- Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Apr 13, 2017
- Initial firm notification
- Press Release
- Center classification date
- May 24, 2017