Recall archive / FDA company announcement
Amneal: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL — FDA announcement Mar 27, 2024
Reported terminated
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Mar 27, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
- Reason
- Super potent due to bottles being overfilled
- Classification
- Not supplied
- Recalling firm
- Amneal Pharmaceuticals, LLC.
- Quantity
- Not supplied
- Agency-reported status
- Terminated in FDA listing
- Source record identifier
- 2ac17743686da5b4
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.; Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email [email protected] for further information and instructions for the product return. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.; NDC No. | Lot | Expiration Date | Pack Size; 69238-2261-3 | 22613003A | 09/2025 | 80 mL; 69238-2261-7 | 22613004A | 09/2025 | 150 mL; 69238-2261-7 | 22613005A | 09/2025 | 150 mL; 69238-2261-5 | 22613005B | 09/2025 | 300 mL |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| NDC No. | Lot | Expiration Date | Pack Size |
|---|---|---|---|
| 69238-2261-3 | 22613003A | 09/2025 | 80 mL |
| 69238-2261-7 | 22613004A | 09/2025 | 150 mL |
| 69238-2261-7 | 22613005A | 09/2025 | 150 mL |
| 69238-2261-5 | 22613005B | 09/2025 | 300 mL |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Mar 27, 2024
- Company announcement date
- Mar 27, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.